PRACTICE APPLICATIONS

Professional Practice

Guiding Global Best Practice in Personalized

Nutrition Based on Genetics: The Development
of a Nutrigenomics Care Map

H
EALTH CARE PROVIDERS nutrigenomics (Step 1), patient model of health and disease, disease
(HCPs) globally, including screening, assessment and informed prevention, and integrative health
dietitians, are encountering consent (Step 2), providing nutrige- care.”2 More recently. The Academy’s
genetic testing for personal- nomics in clinical practice (Step 3), consensus statement indicated that
ized nutrition (ie, nutrigenomics) in and patient follow-up (Step 4). “registered dietitian nutritionists are in
their clinical practice. Although Continuing education was incorporated a position to establish themselves as
considerable basic research examining throughout the care map. A nutrige- objective experts in utilizing [nutrige-
dietegene interactions exists in the nomics care map was successfully nomics] to individualize care by
literature, comparatively less knowl- developed and should be used as a remaining transparent about existing
edge is available regarding the use of starting point to guide clinical practice. evidence, applying clinical expertise
nutrigenomics in clinical practice to This care map is generalizable to die- and training, and participating in
alter dietary outcomes. Despite this, tetics practice globally. research where possible.”5 However,
patients are bringing direct-to- The National Institutes of Health the practical use of nutrigenomics as a
consumer nutrigenomics reports to defines precision (personalized) nutri- tool to optimize diet and health out-
HCPs for interpretation, and more tion as a framework that is focused on comes remains a topic of debate due, in
HCPs are now offering nutrigenomics a number of features relevant to indi- part, to a lack of established clinical
tests to their patients. However, HCPs vidual and population health including guideline documents.5,6 For example,
currently lack clinical guidance docu- genetics, dietary habits, socioeconomic the Academy’s consensus statement
ments in nutrigenomics and several status, and the microbiome, among indicated that there is currently insuf-
steps are needed before full clinical others.1 The concept of personalized ficient evidence, particularly from ran-
practice guidelines are developed. As nutrition in the scientific community domized controlled trials, regarding
a first step in these efforts, our objec- can encompass the use of blood bio- the effectiveness of incorporating
tive was to develop a care map to pro- markers, genetics, epigenetics, protein nutrigenomic testing into nutrition
vide HCPs with a tool for considering abundance, metabolites, and the gut care.5 However, a recent systematic
nutrigenomics in clinical practice based microbiome to tailor nutrition recom- review of randomized controlled trials
on the current state of knowledge. An mendations with the aim of improving concluded that personalized nutrition
Expert Advisory Panel consisting of 6 an individual’s health. The increasing interventions (including those that are
nutrigenomics researchers, 3 of whom availability and affordability of genetic based on genetics) can enhance dietary
are also registered dietitians (RDs), testing has prompted many consumers behavior changes to a greater extent
developed a care map draft while to purchase direct-to-consumer (DTC) than standard population-based
consulting nutrigenomics literature genetic tests and bring these reports to advice.7 Despite this ongoing debate,
and incorporating the 3 key pillars of their HCPs for interpretation. Further- nutrigenomics is becoming more com-
personalized nutrition. To optimize more, this has prompted several HCPs mon in clinical practice, with research
generalizability, the draft was reviewed to incorporate genetic testing into their suggesting generally positive attitudes
by 12 HCPs with representation from 6 practice.2 The term nutrigenomics is toward this area of nutrition by HCPs
continents (Africa, Asia, Australia, used to describe the application of ge- and patients alike.8-11
Europe, North America, and South netic information to personalize nutri- Although attitudes toward nutrige-
America) who have experience using tion recommendations.3 A recent nomics are generally positive and
nutrigenomics in their clinical practice. statement from the American Nutrition nutrigenomics is already a component
The Expert Advisory Panel revised the Association declared that “personalized of clinical practice for many practicing
care map based on HCP feedback and nutrition is the most powerful antidote HCPs, concerns have been raised about
all members of the Expert Advisory to chronic disease,”4 and the Academy the lack of industry regulation and
Panel approved the final version. A 4- of Nutrition and Dietetics’ (Academy) scientific validity of some nutrige-
step care map was developed, with 2017 Visioning Report stated that, with nomics tests.12,13 In addition, more
sections related to HCP training in respect to personalized nutrition, RDs research is needed to better assess
“can assume an increasingly important the impact of incorporating genetic
role in the emerging health care system testing into nutrition counseling for
https://doi.org/10.1016/j.jand.2021.02.008 that focuses on a genetic predisposition improving dietary intake and health

ª 2021 by the Academy of Nutrition and Dietetics. This is an open access

article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/). JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS 1
PRACTICE APPLICATIONS

Figure. Nutrigenomics care map. DTC ¼ direct-to-consumer; HCP ¼ health care provider; SMART ¼ specific, measurable, attainable,
relevant, and time-based.

outcomes.6,14,15 Furthermore, knowl- care settings. The purpose of this care choose to offer nutrigenomics in clin-
edge of nutrigenomics among HCPs is map is to provide a tool for the nutri- ical practice and/or who are presented
variable,8,10,16 and many have stressed genomics process in clinical practice with DTC nutrigenomics reports from
the importance of incorporating for adult patients. Of note, the present patients. In addition to consideration of
greater training in nutrigenomics into care map builds directly on the Aca- nutrigenomics, which is 1 of the 3 key
university and continuing education demy’s recent consensus statement on pillars of personalized nutrition,28 the
curricula10,16-19 and RDs have recently incorporating genetic testing into di- Panel also considered general nutrition
expressed interest in completing etetics practice, as well as the position recommendations29 based on factors
further training in nutrigenomics.8 statement of the Academy on nutri- such as age, sex, and social de-
With the current reality of nutrige- tional genomics.5,6 terminants of health, as well as indi-
nomics being an increasingly more vidualized nutrition recommendations
common component of dietetics prac- based on phenotypes. Therefore, all 3
tice (either through patients bringing METHODS pillars of personalized nutrition were
DTC results to their consultations or accounted for during care map devel-
through HCPs offering nutrigenomics Nutrigenomics Expert Advisory opment. More specifically, according to
testing in their practice), guiding HCPs Panel the International Society of Nutrige-
toward ethical practice is essential. The Expert Advisory Panel consisted of netics and Nutrigenomics, these pillars
Therefore, clinical guidance documents 6 nutrigenomics researchers, 3 of include the following: general nutri-
for HCPs are needed. whom are also RDs. One of the RDs tion recommendations based on
Care maps are valuable starting previously used nutrigenomics in her population-based studies for various
points that provide useful templates clinical practice. This Panel developed age groups, sex, and social de-
and guidance20 to help implement the draft of the care map based on terminants of health; individualized
evidence-based practice.21,22 They are brainstorming sessions of potential nutrition recommendations based on
used in a variety of areas of health care, options at each decision point, consid- phenotype (eg, anthropometric,
such as health management,23,24 guid- eration of health behavior change (see biochemical, clinical examination
ance of surgical care procedures,25,26 details below), personal clinical expe- data); and genetic-based recommen-
and provision of family-centered rience, and consideration of peer- dations for personalized nutrition.28
care.27 Although nutrigenomics is reviewed literature deemed most rele- The Expert Advisory Panel provided
becoming more common in clinical vant to the development of the care additional feedback throughout re-
practice, a care map has not been map. The key priority of this care map visions of the draft and approved the
developed for nutrigenomics in health was to provide guidance to HCPs who final version of the care map.

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 PRACTICE APPLICATIONS

Consideration of Facilitating an RD, and 1 was a molecular geneti- provide a strong basis for nutrition
Health Behavior Change cist. Feedback was used to develop the knowledge, as well as foundations of
Providing nutrition care in clinical final care map. The HCP peer review cellular and molecular biology,46,47 but
practice should follow the Nutrition process took approximately 3 months additional training in nutrigenomics
Care Process model, which includes the to complete. can be beneficial. To our knowledge,
consideration of optimizing behavior nutrigenomics is not considered a
change related to nutrition.30 An CARE MAP OVERVIEW controlled act under provincial/state
assessment tool for evaluating the A 4-step nutrigenomics care map was and national legislation; thus, almost
quality of nutrigenomics interventions, developed, with ongoing continuing all HCPs (and not just RDs) can provide
based on the format of the National education essential throughout the these genetic tests in their practice,
Institutes of Health’s Study Quality clinical process. The final nutrige- with only a few exceptions. For
Assessment Tools, was developed pre- nomics care map is presented in the example, naturopaths in Ontario, Can-
viously31 and, to our knowledge, is the Figure, with a case study example ada, are not permitted to collect saliva
only tool that is currently available in detailed in Boxes 1 through 4. It is samples and order genetic tests48,49;
this area. This assessment tool was important to note that as knowledge however, they are still permitted to
established based on literature identi- regarding the impact of genetic testing interpret the results of DTC genetic
fying strengths and limitations related in clinical practice continues to evolve, tests with their clients. RDs, who are
to nutrigenomics, genetic testing, and we anticipate that this first iteration of regulated HCPs with a strong back-
health risk messages.32-40 The 5 discrete the nutrigenomics care map will be ground knowledge in evidence-based
components of this assessment tool updated accordingly. nutrition, are the ideal source of
were used to develop the core structure nutrigenomics because they are legally
of the care map. These components required (and overseen by regulatory
considered the following: the involve-
Step 1: HCP Preparation bodies) to uphold the highest stan-
ment of HCPs in the interpretation of HCP Education and Training. Given dards of confidentiality, security of
results, provision of actionable genetic that nutrigenomics is a specialized area, documentation, and ethics.50-54 Nutri-
results, providing a copy of reports for specific education and training are genomics tests can provide information
patients, ensuring patient comprehen- needed for HCPs. This area of nutrition on nutrient metabolism (eg, nutrient
sion, and patient follow-up.31 has unique legal and ethical consider- absorption and conversion rates),55,56
ations, which we encourage HCPs to risk of food intolerances (eg, genetic-
learn more about through further based risk of lactose intolerance or ce-
Peer Review by HCPs Using reading.41-44 These considerations liac disease),57,58 and risk factors of
Nutrigenomics in Practice relate to topics including informed chronic disease (with nutritional guid-
HCP peer reviewers were identified consent, the nature of the genetic test ance to mitigate risk factors),59 among
through convenience sampling within (ie, the type of results, such as those others. To our knowledge, none of the
the Expert Advisory Panel’s broad that relate to weight, food intolerances, current nutrigenomics tests available
professional network, followed by and athletic performance), implications to patients include information that
snowball sampling from the HCPs’ of the genetic variants tested (eg, would be considered diagnostic, but as
networks. The Expert Advisory Panel pleiotropic effects in which a genetic knowledge continues to advance and
contacted HCPs from 6 continents (via variant has nutrigenomics implications new tests become commercially avail-
e-mail) who had experience using but also disease risk implications43), able, this is important for HCPs to
nutrigenomics in their clinical practice. scientific validity, and data sharing, consider from a scope of practice
HCP peer reviewers were asked to among others.41-43 Notably, clinical perspective. Furthermore, several DTC
provide any feedback related to face practice guidelines (CPGs) do not yet genetic tests include genetic informa-
validity, accuracy, and completeness, exist for nutrigenomics. CPGs are tion related to nutrition, in addition to
with particular attention on whether important to clinical practice, as they genetic information related to risk of
the care map was easy to follow; help to provide a clear summary of ev- diseases, where personalized nutrition
whether the care map provided an ac- idence available to inform a particular advice beyond general recommenda-
curate account of how to best incor- practice question or topic, and tions for healthy eating may not apply.
porate nutrigenomics into practice; contribute to patient-centered care.45 For example, patients may receive in-
and whether there were any flaws or With a current absence of CPGs formation about BRCA1 and BRCA2 ge-
pitfalls in the care map. Twelve HCPs related to nutrigenomics, HCPs must notype as they relate to breast cancer
with representation from 6 different seek training from different sources. risk.60 In such cases, HCPs practicing in
continents (Africa, Asia, Australia, In addition to having a strong back- nutrition must recognize that it is
Europe, North America, and South ground in evidence-based nutrition outside of their scope of practice to
America) reviewed the care map and and ethical health care practices, HCPs provide health recommendations
supporting text for face validity, accu- should seek to have confidence and based on these results and should refer
racy, and completeness, and provided competence in their knowledge of the patient to the appropriate HCP
the Expert Advisory Panel with feed- basic genetics, legal considerations (physician or genetic counselor).
back on the draft. Responses were relevant to genetic testing, and clinical Several resources exist for HCPs to
open-ended and were returned to the interactions with patients undergoing further their knowledge in nutrige-
Expert Advisory Panel via e-mail. Ten nutrigenomics testing. Accredited nomics, including more than 35 cour-
of the HCPs were RDs, 1 was previously nutrition and dietetics programs ses offered globally ranging from short

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PRACTICE APPLICATIONS

online presentations to university-level To help ensure analytic validity, acknowledge that even population-
courses and graduate degrees that are accredited laboratories should be used based dietary recommendations are
detailed elsewhere.61,62 For HCPs in for the genetic analysis. Laboratory created from the highest level of
which nutrigenomics is a component of accreditation processes differ from one available evidence, for which inter-
their practice, available training pro- country to another. For example, the vention studies are often not avail-
grams should be assessed for areas United States has strict regulations for all able.74-76 With respect to clinical utility,
where they feel they require more laboratories, whereas in Canada the growing evidence indicates that DNA-
knowledge. For example, peer-reviewed accreditation and regulatory processes based dietary recommendations may
literature can provide insightful infor- vary from province to province.13 HCPs motivate positive dietary changes,
mation into the ethical considerations should further be aware of whether the which is an important component of
specific to nutrigenomics, which can be company shares genetic information and clinical utility that warrants consider-
used to further enhance knowledge in data with third-party companies, and ation for the use of evidence-based
this area.13,41-43,63 University-affiliated this should be included in the informed nutrigenomics tests in practice.31,77
courses and courses offered by regula- consent process (as discussed in Step 2). Box 1 provides a case study overview
tory bodies/professional associations The scientific validity of consumer of Step 1.
can provide a beneficial combination of genetic information and nutrigenomics
education on both the scientific evi- testing is sometimes criticized, with
dence and the practical application of critics suggesting a lack of evidence for Step 2: Patient Screening,
nutrigenomics. Genetic testing com- demonstrated genetic differences in Assessment, and Informed
panies may provide training materials biologic changes after a dietary inter- Consent
and representatives for consultation. vention.66-69 Although a number of
Although caution is warranted for ma- intervention studies exist showing in- Screening and Nutrition/Health
terials offered by private companies due dividual genetic-based responses to Assessment. First, it should be rein-
to the potential for biased representa- nutritional interventions,70-72 observa- forced that the purpose of this care
tions of the science, HCPs should review tional associations currently make up map is to guide the personalized
the company’s credentials (eg, whether the majority of the evidence base.73 As nutrition process in clinical practice in
members—researchers and HCPs—of the more clinical trials using nutrige- adult patients, given that there are
Scientific Advisory Board have nutrige- nomics are conducted, systematic re- different considerations for pediatric
nomics and evidence-based nutrition views of this research will further patients. In cases where the HCP offers
training) as an increasing number of clarify the impact of using genetic in- nutrigenomics in their clinical practice,
scientists and clinicians are involved in formation in practice to modify dietary before undergoing nutrigenomics
the development of companies that outcomes. However, it is important to testing, all patients should be screened
provide genetic tests.

Reviewing Nutrigenomics Tests.

There are several considerations when
Box 1
reviewing various nutrigenomics tests.
(Corresponding to Care Map Step 1): HCP Preparation (Case Study)
These considerations relate to analytic  An HCP has completed an accredited undergraduate program in
validity; scientific validity; clinical util- nutrition and dietetics, and a dietetics internship, and owns a private
ity; and ethical, legal, and social impli- practice. They are interested in providing nutrigenomics testing to
cations, which have been further their patients.
discussed at length elsewhere64,65 and  Because of their background education, they feel competent in their
are also relevant to the review of DTC knowledge on the basics of nutrition and genetics. Thus, they seek out
nutrigenomics tests that patients may training in the areas of ethics, evidence-based nutrigenomics in-
bring to an HCP for interpretation. Ana- teractions, and the application of nutrigenomics in clinical practice.
lytic validity refers to the accuracy of  To better understand ethical considerations of nutrigenomics, they
genotyping, scientific validity refers to decide to review 2 scientific articles (eg, Hurlimann and colleagues42
the strength of the scientific evidence for and Castle and Ries41)
gene-diet interactions, and clinical util-  In order to improve their knowledge on the science of nutrigenomics,
ity refers to the potential for the infor- they review the available training opportunities and decide to enroll in
mation (and subsequent advice) to a course at an academic institution (eg, Collins and colleagues61)
promote beneficial dietary changes and  To gain knowledge on the practical application of nutrigenomics and
positive health-related outcomes.64,65 further their understanding of evidence-based nutrigenomics in-
These topics have been discussed at teractions, they sign up for an online course (eg, Dietitians of Canada
length elsewhere; we direct HCPs to course on Nutrigenomics and Personalized Nutrition [https://courses.
these works to gain a deeper under- dietitians.ca/course/search.php?q¼nutrigenomics&areaids¼core_
standing of validity and utility related to course-course])
nutrigenomics.64,65 It is important to  They also review the present care map to assist in planning to incor-
note that if a test does not have analytic porate nutrigenomics into their practice.
validity, scientific validity, and clinical  When selecting which nutrigenomics test to use, they carefully
utility for the patient, it should not be consider the scientific validity, clinical utility, and nature of the test.
used in clinical practice.

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to identify potential contraindications the patient and determine whether the codes are then linked to the patient’s
for nutrigenomics testing (eg, patients test will meet the patient’s expecta- names in their own files but are not
with eating disorders for tests with tions. If yes, then the HCP proceeds to visible to the company. This practice is
weight-loss response results; patients the informed consent process if the intended to provide an additional level
with low income who may not be patient wishes to undergo nutrige- of security and confidentiality of the
willing/able to afford this testing). The nomics testing. In some cases, a patient patients’ genetic information.
HCP also has a responsibility to may be more interested in medical Box 2 provides a case study overview
consider costebenefit of genetic genetics or pharmacogenomics and a of Step 2.
testing, taking into account the pa- referral to the appropriate HCP is
tient’s reasons for wanting to pursue advisable if this work is outside of the
testing, financial willingness and abil- nutrition HCP’s scope of practice. Step 3: Providing Nutrigenomics
ity, and health status/family history. Detailed information about the rec- In Clinical Practice
When costebenefit justification is not ommended informed consent process
met, or there is no evidence to support for nutrigenomics has been detailed Appointments with Patient to
the use of a particular genetic test in a elsewhere.42 Although DTC companies Collect Sample and/or Review
subset of the population, or significant have informed consent processes at Results. When the HCP is offering
contraindications exist, then the HCP time of purchase, when genetic testing nutrigenomics in their practice, a DNA
has a responsibility to advise the pa- is done through HCPs, the HCP is sample (typically saliva or buccal swab)
tient against proceeding with nutrige- responsible for obtaining the informed is collected and sent for genetic anal-
nomics testing. The screening process consent from all patients before they ysis. This process has been outlined in
may happen in person during a patient undergo nutrigenomics testing. The detail elsewhere.13 Companies may
appointment, or the HCP may send the HCP should keep a copy of the signed have specific instructions for collecting
patient an assessment form to better consent form in the patient’s chart, and the sample, such as avoiding eating or
understand the patient’s anthropo- the patient should also receive a copy. smoking 30 minutes before sample
metric, biochemical, clinical, and di- The consent process should include collection. The length of time between
etary intake data. The screening and information related to the nature of the the sample collection and follow-up
assessment process can also be an test and recommendations, pros and appointment is dependent on the
opportune time to identify health cons of the test, information related to amount of time needed for the nutri-
considerations that could impact gen- privacy, potential added value to the genomics testing company to analyze
eral nutrition recommendations, such nutrition care plan, and legal implica- the sample and send the report to the
as food allergies, chronic kidney dis- tions, such as the potential for genetic HCP.
ease, or type 2 diabetes. These may discrimination in some countries82 or When preparing for the appointment
impact some of the recommendations obligations to disclose the results of to communicate or review nutrige-
detailed in the nutrigenomics report. certain genetic tests.83 Some HCPs may nomics results, the HCP should review
Furthermore, this is a beneficial time to choose to de-identify patients (and the patient’s results on their own to
identify the patient’s health and nutri- instead use codes in place of names) ensure their comprehension. If the HCP
tion goals and establish priorities. In when using online company platforms requires clarification about any
addition, the HCP should consider key to link test kits to patient results; these component of the report, they should
determinants of behavior change and
validated behavioral theories (eg, see
Prochaska and Velicer78 and Ajzen79), Box 2
and use this information to help guide (Corresponding to Care Map Step 2): Patient Screening, Assessment
their counseling to promote behavior
and Informed Consent (Case Study)
change. Based on this assessment, the
HCP should determine whether nutri-  The HCP is now prepared to incorporate nutrigenomics into their
genomics testing is appropriate for the practice. During an initial assessment, patient “JD” expresses interest in
patient, or if a personalized nutrition undergoing nutrigenomics testing.
plan that does not incorporate genetic  Based on the initial assessment, the HCP does not identify any con-
information is sufficient (eg, see traindications to proceeding with this test.
Celis-Morales and colleauges80). For  JD identified cardiovascular disease management and prevention as an
example, HCPs may wish to exercise area of health priority. JD is taking medication for hypertension and
caution in the decision to pursue their recent blood work demonstrated elevated triglyceride levels of
certain nutrigenomics tests for patients 4.2 mmol/L (to convert mmol/L triglycerides to mg/dL, multiply mmol/
with eating disorders (eg, some tests L by 88.6). JD has a strong family history of myocardial infarction and
include information on weight loss) dyslipidemia. They also have a personal history of recurring calcium
and ensure that the potential benefits oxalate kidney stones. The HCP sees potential added value to the
of the information for the patient nutrition care plan if the patient were to receive genetically guided
outweigh potential harms, based on nutrition advice.
established counseling guidelines for  Therefore, the HCP proceeds with completing written informed con-
eating disorders.81 If nutrigenomics is sent with JD, who agrees and signs a consent document that is kept in
determined to be appropriate, the HCP their secure chart.
should explain the nature of the test to

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PRACTICE APPLICATIONS

consult the scientific literature or throughout the report, so that the pa- information that was not part of the
potentially contact the company for tient can easily review this informa- original test results, as various software
clarification. It is acknowledged that tion, as needed, after the appointment. is available online to perform this kind
although reviewing scientific literature When reviewing the results, the HCP of analysis.89 HCPs should follow the
is ideal, it can be both challenging and may need to adjust some nutrition same principles indicated in Steps 1
time-consuming, reinforcing the recommendations based on individu- and 2 when reviewing genetic results
importance of adequate training and alized patient considerations (eg, food brought by the patient.
the need for CPGs among HCPs who allergies/restrictions or disease). In Box 3 provides a case study overview
wish to offer nutrigenomics tests. addition, patients should be aware that of Step 3.
HCPs should use a patient-centered their health may change over time and,
approach for the appointment in as such, nutrition recommendations
which nutrigenomics results are dis- may also change. To help ensure pa-
Step 4: Patient Follow-Up
closed and reviewed. In some cases, tient comprehension, it is important to Follow-up appointments are ideal for
multiple appointments to review the use simple language and repeatedly optimizing patient comprehension, as
results may be warranted, especially as check-in with the patient to ask well as for monitoring/assessing nutri-
knowledge in the field continues to whether they have any questions, or tion behavior change and health.
grow and nutrigenomics tests include whether they would like specific sec- Indeed, a single intervention session is
more and more information. Therefore, tions revisited/repeated. Different less likely to facilitate behavior
setting priorities is of great importance counseling techniques can be used in change.90 Therefore, it is recommended
to the nutrigenomics care process an effort to optimize understanding. that the patient book at least 1 follow-
and, more generally, the nutrition For example, the testefeedback up appointment. In many cases, pa-
care process.30 In addition, the results of approach and teach-back method tients are seeing a fee-for-service HCP
the nutrigenomics test should be have been shown to improve patients’ and paying for nutrigenomics tests;
considered alongside anthropometric, comprehension of information pre- thus, costebenefit considerations must
biochemical, clinical, and dietary intake sented in appointments with HCPs.85-87 be made throughout the nutrigenomics
data.84 Indeed, the HCP should consider Patient comprehension also includes care process. The purpose of a follow-
phenotype and/or blood work results in ensuring that the patient understands up appointment is to review the pa-
conjunction with nutrigenomics results. practical strategies to help achieve the tient’s progress (with respect to nutri-
For example, if a patient’s nutrige- nutrigenomics recommendations sug- tion habits and changes in any
nomics report indicates an elevated risk gested in the report. At the end of the measured biomarkers), answer any
for lactose intolerance but the patient session, the HCP and patient should questions the patient may have, review
exhibits no signs or symptoms of work together to identify 1 to 3 specific, priority areas of nutrition care, review
gastrointestinal discomfort, then it may measurable, attainable, relevant, and SMART goals set in the previous ses-
be unnecessary for the patient to limit time-based (SMART) goals88 for the pa- sion, and set new SMART goals if the
their intake of lactose-containing prod- tient to focus on. Additional resources, patient is ready. The number and
ucts. In addition, in cases where a ge- such as recipes, handouts, and digital duration of follow-up appointments
netic report includes information that is tools (including apps), can also be pro- required should be decided between
outside of the HCP’s scope of practice vided or recommended to the patient as the HCP and the patient based on the
(eg, BRCA1/2 genetic testing for breast needed. HCPs may further recommend patient’s needs and wants. If a patient
cancer risk), they should refer the pa- that patients complete specific labora- declines immediate follow-up, the HCP
tient to the appropriate HCP for inter- tory tests for biomarkers relevant to the should ensure that the patient has the
pretation of such results. patient’s nutrigenomics report. Overall, appropriate contact information in case
To begin the appointment, the HCP the HCP should allot approximately 60 they decide to book an appointment at
should start by providing an explana- minutes for this first nutrigenomics re- a later date, and should ensure that the
tion of basic information about ge- view session. Including follow-up ap- patient is aware that they can return
netics so that the patient can pointments for further review is an for follow-up at any time. Follow-up
understand the different components important component of the nutrition data (eg, changes in nutrition or bio-
of the report (although some HCPs may care process for nutrigenomics, but also markers) can also be used to inform in-
choose to provide this information for general nutrition counseling. house research for the HCP’s practice.
during the informed consent meeting). This guidance is intended for a sce- Box 4 provides a case study overview
Specifically, the HCP should provide an nario of nutrigenomics testing being of Step 4.
overview of how genes play a role in offered in practice; however, it is
nutrition (eg, metabolism, absorption, becoming more common for patients DISCUSSION
and taste preferences), genetic vari- to visit an HCP with raw genetic infor- To our knowledge, this is the first care
ants/genotypes and how these differ mation or DTC reports in hand. map in the field of nutrigenomics. This
from person to person, and other rele- Before reviewing reports, HCPs article advocates neither for nor
vant genetic-related information should advise patients about the vari- against the use of nutrigenomics in
appearing in the nutrigenomics test able scientific validity of DTC tests clinical practice. Rather, this care map
report that an HCP would not expect a resulting in part from lack of industry represents a practical tool that should
patient to understand (eg, genes and regulation.13 Some patients may be used by HCPs who are using nutri-
alleles). The HCP should also explain make use of raw genetic data to genomics in their clinical practice or
where to find different information generate nutrigenomics-related who are considering doing so. It should

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also be used by HCPs who experience

Box 3 patients that bring genetic testing re-
(Corresponding to Care Map Step 3): Providing Nutrigenomics in sults obtained elsewhere to their ap-
Clinical Practice (Case Study) pointments for interpretation.
The development of this care map
 The HCP collects a saliva sample from JD, sends it to the testing com-
was deemed of high importance, given
pany, and books a follow-up appointment 3 weeks after JD’s initial
the current reality that patients, re-
assessment. The HCP and JD discuss what results they will give priority
searchers, and HCPs are highly inter-
to in their follow-up appointment.
ested in personalized nutrition.91,92
 When the HCP receives the report, they determine (based on JD’s initial
Care maps have been developed and
assessment) that special consideration related to some of the recom-
used successfully in many areas of health
mendations outlined in the nutrigenomics report will require adjust-
care, such as metabolic syndrome, dys-
ments; JD has special dietary considerations related to dietary calcium,
lipidemia, family-centered care, chronic
sodium, and high oxalate foods given their recurring calcium oxalate
disease prevention, and screening, as
kidney stones. As identified during JD’s initial appointment, cardio-
well as surgical care.23-27,93 In some
vascular disease prevention is a priority for the patient. Therefore, this
regards, this nutrigenomics care map is
is the focus of the appointment.
more complex than others, given that
 At the follow-up appointment, the HCP provides JD with an overview
the field of nutrigenomics has unique
of genetics and then reviews the results from the nutrigenomics report,
considerations and is an evolving area.
while spending extra time and attention on sections relevant to car-
These considerations relate to HCP
diovascular health.
training, scientific validity of nutrige-
 The HCP checks in with JD throughout the appointment, to ensure the
nomics tests, regulation, and others, and
patient understands the report. They use the testefeedback method in
have been outlined throughout this
their counseling. JD asks for further clarification about which foods
work and elsewhere.41-43,64 In compari-
contain a-linolenic, eicosapentaenoic, and/or docosahexaenoic n-3
son to care maps in other areas of health
fatty acids (the patient has the GG genotype of FADS1 rs174537), so the
care, this nutrigenomics care map differs
HCP reviews this section of the report again.
in that there are 4 concrete steps
 At the end of the appointment, JD sets 3 SMART goals, with the help of
involved, with the first step typically
the HCP. These goals are developed based on the results of the nutri-
completed only once by the HCP, and
genomics test in addition to the patient’s personal general nutrition
steps 2 to 4 completed with each new
and health assessment. Starting today, JD plans to:
patient. This care map represents the
1. Continue including 1 egg at breakfast 5 days of the week, but
first tool for the use of nutrigenomics in
switch to n-3 eggs cooked in 1 Tbsp canola oil and add 1 Tbsp
practice; however, we anticipate that
ground flaxseed to yogurt
updates to this care map will be required
2. Eat 3 oz of salmon, for 3 meals this week
as both the basic science and evidence
3. Review the cardiovascular health sections of the nutrigenomics
regarding clinical uptake progress. This
report over the next 2 weeks
care map was developed through expert
 The HCP provides JD with a copy of the nutrigenomics report and they
consensus, which is considered lower-
decide to book a follow-up appointment in 3 weeks to review JD’s
level evidence,94 and future research
progress with their goals and to potentially set new SMART goals.
should assess the use of this care map in
clinical practice. Furthermore, we
acknowledge that this care map repre-
sents a first step toward the develop-
ment of CPGs. In order to develop CPGs
Box 4 for nutrigenomics, more systematic re-
(Corresponding to Care Map Step 4): Patient Follow-Up (Case Study) views of geneediet interactions are

needed. These reviews should include an
JD returns for their follow-up appointment. JD has achieved all of their
evidence grading method and should
SMART goals!

follow established CPG methodology,
JD brings a list of questions related to the basics of genetics, and brings
such as the use of AGREE II instrument.95
up another question about the result from their nutrigenomics test
These systematic reviews can ascertain
related to caffeine and the CYP1A2 genotype. The HCP reviews the
whether the evidence for individual
information on the basics of genetics and clarifies the nutritional im-
dietegene interactions is low, moderate,
plications of JD possessing the AA genotype of CYP1A2 (rs2472300).
or high quality, for example, through the
They use the teach-back method to help ensure that they are providing
use of the GRADE (Grading of Recom-
an explanation that JD understands.

mendations, Assessment, Development
Based on this discussion, JD decides to set 1 new SMART goal; they aim
and Evaluation) approach.96 We antici-
to limit caffeine intake to the equivalent of 2 cups (500 mL) of coffee
pate that such reviews will clarify dis-
per day. JD is confident that they will be able to achieve this goal, but is
cussions about scientific validity and
hesitant to set other additional new goals at this point in time.

help determine whether specific
JD books another follow-up appointment in 3 weeks to provide a
geneediet interactions are ready for
source of accountability.
clinical practice. As knowledge

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PRACTICE APPLICATIONS

continues to advance, this nutrige- profession. J Acad Nutr Diet. 2017;117(1): health outcomes: An evidence analysis
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AUTHOR INFORMATION
Address correspondence to: Justine R. Horne, PhD, RD, Centre Nutrition, Santé et Société, Institut sur la nutrition et les aliments fonctionnels,
Université Laval, 2440 Hochelaga Blvd, Quebec, QC, Canada G1V 0A6. E-mail: [email protected] or David M. Mutch, PhD, Human Health
and Nutritional Sciences, University of Guelph, Guelph, 50 Stone Rd E, Guelph, ON, Canada N1G 2W1. E-mail: [email protected]
This article was written by J. R. Horne, PhD, RD, postdoctoral fellow, Centre Nutrition, Santé et Société, Institut sur la nutrition et les aliments fonc-
tionnels, Université Laval, Quebec City, Quebec, Canada, and School of Nutrition, Université Laval, Quebec City, Quebec, Canada; at the time of the study,
she was a PhD candidate, Health and Rehabilitation Sciences, Western University, London, Ontario, Canada; Daiva E. Nielsen, PhD, Assistant Professor,
School of Human Nutrition, McGill University, Montreal, Quebec, Canada; Janet Madill, PhD, RD, FDC, Associate Professor School of Food and Nutritional
Sciences, Western University, London, Ontario, Canada; Julie Robitaille, PhD, RD, Full Professor, Centre Nutrition, Santé et Société, Institut sur la nutrition
et les aliments fonctionnels, Université Laval, Quebec City, Quebec, Canada, and School of Nutrition, Université Laval, Quebec City, Quebec, Canada;
Marie-Claude Vohl, PhD, Full Professor, Centre Nutrition, Santé et Société, Institut sur la nutrition et les aliments fonctionnels, Université Laval, Quebec
City, Quebec, Canada, and School of Nutrition, Université Laval, Quebec City, Quebec, Canada; and David M. Mutch, PhD, Associate Professor,
Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, Canada.
STATEMENT OF POTENTIAL CONFLICT OF INTEREST
No potential conflict of interest was reported by the authors.
FUNDING/SUPPORT
M. C. Vohl is a Tier 1 Canada Research Chair in Genomics Applied to Nutrition and Metabolic Health. J.R. Horne was supported through post-
doctoral fellowships from the Centre Nutrition, Santé et Société, the Institut sur la nutrition et les aliments fonctionnels, and the Canadian
Institutes of Health Research (Doctoral Research and Postdoctoral Fellowship Awards).
ACKNOWLEDGEMENTS
The authors would like to thank the following HCPs for critically reviewing the care map figure and associated text and providing valuable
feedback: Mariette Abrahams, PhD, RD (England), Melissa Adamski, MND, APD, PhD (candidate) (Australia), Chelsea Bezerra, RD (Brazil), Jerusa
Brignardello, MSc, RD, PhD (candidate) (England, Chile), Flavia Fayet-Moore, PhD, MND, APD (Australia), Julie Freeman, MA, RD, LDN (United
States), Denise Furness, PhD (Australia), Nicqui Grant, RD (South Africa), Yael Joffe, PhD, RD, FACN (South Africa), Paige McDonald, MScFN, RD
(Canada), Marina Pioltine (Brazil), MSc, RD and Janani Tamilvanan, MSc, MPhil, PhD (candidate) (India). All HCP peer reviewers who were involved
in critically reviewing the care map have current or previous experience offering nutrigenomics testing in their clinical practice. This was deemed
essential to obtain feedback regarding the current reality that HCPs are already using and/or encountering genetic testing in nutrition practice.
AUTHOR CONTRIBUTIONS
All authors helped to conceptualize and design the study. J. R. Horne and D. M. Mutch drafted the manuscript and were responsible for the HCP
peer review process with RDs/HCPs. J. R. Horne, D. M. Mutch, J. Madill, D. E. Nielsen, J. Robitaille, and M.-C. Vohl revised manuscript drafts. J. R.
Horne and D. M. Mutch had primary responsibility for the final content. All authors reviewed and approved the final manuscript. None of the
authors are currently offering nutrigenomics in clinical practice.

10 JOURNAL OF THE ACADEMY OF NUTRITION AND DIETETICS -- 2021 Volume - Number -