Precision Nutrition Impact on Health-Related Behavior Change
Study Details
Study Description
Brief Summary
A prospective, randomized, controlled trial enrolling up to 150 service members (SMs) from two sites; Joint Base Lewis McChord (JBLM) in the Northwest and Joint Base San Antonio (JBSA)-Lackland in the Southwest. A baseline genomic profile (70 genes/80 single nucleotide polymorphisms [SNPs]) augmented by common serum biomarkers specific to diet-related chronic disease (metabolic syndrome, cardiovascular disease [CVD], vitamin D deficiency) risk will be created. Subjects will be randomized to either personalized nutrition counseling or standard nutrition education for 6 weeks. This interval matches Service-run healthy weight initiatives such as the Army's current Fit for Performance Program. To promote self-care and engagement, a digital app will be utilized for 2 weeks for real-time health data capture with continuous feedback and will be validated with in-person RD interviews. Physical activity and injury data, sun exposure, and family history will help elucidate unique individual responses. Participant follow-up at 12 weeks will evaluate changes in anthropometrics and metabolic, cardiovascular, and vitamin D biomarkers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Precision nutrition leverages the specificity of molecular and phenotypic differences in personalizing diet and lifestyle interventions. Specific Aims: 1) Examine the effectiveness of gene-based nutrition counseling on health-related behavior change in service members as measured by body weight, body mass index (BMI), blood glucose, lipids, 25-hydroxyvitamin (OH) D, %body fat (BF), waist circumference, and blood pressure; 2) Evaluate the feasibility of a digital application to accurately capture diet, activity, and sleep behaviors; and 3) Describe military-unique characteristics in demographics, diet, and lifestyle for northwest Army and southwest Air Force cohorts.
A baseline genomic profile will be created from 70 diet-responsive genes and 80 variants following amplicon sequencing on an Illumina MiSeq platform and will be informed by serum biomarkers specific to diet-related chronic disease risk (i.e. metabolic syndrome, vitamin D deficiency) for each subject. Risk variants were selected if minor allele frequency > 5% and at least two published papers verified the link to the phenotype of interest. Treatment group receives gene-based nutrition counseling for six weekly sessions; Controls receive evidence-based nutrition pamphlets, all content directed at preventing metabolic syndrome. A digital app provides real-time health data capture with continuous feedback and is verified by in-person dietitian interviews. Both groups will also use study resources independently for six weeks, returning for final body composition and serum biomarkers after the twelve-week intervention. The control group receives the genomic profile with dietary recommendations upon study completion. Data analysis will examine between-group and by-cohort differences on primary anthropometric and biomarker outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group or counseling group The treatment group will receive a counseling intervention addressing metabolic syndrome (comprised of abdominal adiposity, high blood pressure, high cholesterol, elevated fasting glucose, and elevated triglyceride level) and low vitamin D. This group will undergo baseline body composition measurements, phlebotomy, and an introduction to the digital app for recording diet and activity. |
Other: Professional nutrition counseling
Published multi-cohort genome-wide association studies provided genes and genetic variants that are credibly associated with aspects of metabolic syndrome (MetS), CVD, overweight/obesity, and vitamin D metabolism. Registered dietitian (RD) counseling will review potentially harmful and protective variants for risk of MetS with subjects and make evidence-based recommendations to improve diet quality and achieve weight loss goals. Each of the 6 weekly sessions covered a specific component of MetS. Counseling will take place once a week either in-person or via phone/virtual platform based on preference and availability of the subject. Counselors will review digital app data entries for food intake prior to this interaction for the first 2 weeks.
Other Names:
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| Active Comparator: Control group or comparison group Subjects randomized to the control group will undergo baseline body composition measurements, phlebotomy, and an introduction to the app for recording diet and activity. They will receive a packet of evidence-based pamphlets addressing Service-specific approaches to healthy eating and physical activity (e.g. Performance Triad). There will be no formal recurring interaction with an RD for those randomized to this control group. |
Other: No professional nutrition counseling
Participants receive pamphlets with evidence-based general health, healthy nutrition, exercise and sleep content. They receive information on genetic variants related to MetS at end of study period.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Weight loss [12-14 weeks]
Pounds lost between measurements
Secondary Outcome Measures
- Body fat [12-14 weeks]
Percent change in body fat over time
- Waist circumference [12-14 weeks]
Change in waist circumference measured in inches to reduce risk for MetS over time
- Serum Cholesterol [12-14 weeks]
Blood level of serum cholesterol to reduce risk for MetS over time
- Systolic blood pressure [12-14 weeks]
Change in systolic blood pressure to reduce risk for MetS over time
- Diastolic blood pressure [12-14 weeks]
Change in diastolic blood pressure to reduce risk for MetS over time
- Serum glucose [12-14 weeks]
Change in blood glucose level to reduce risk for MetS over time
- Serum triglyceride [12 -14 weeks]
Change in blood triglyceride level to reduce risk for MetS over time
Eligibility Criteria
Criteria
Inclusion Criteria:
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Active duty Army or Air Force
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Age 18-45
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Able to read and comprehend English
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Assigned to JBLM or JBSA-Lackland,
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Remaining on station for 5 months
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Consider self generally healthy
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History of or currently out of compliance with military fitness standards
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Willing to submit 2 blood samples including one for gene testing
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Willing to undergo 1 DEXA scan (JBLM only)
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Willing to participate in 6 weekly nutrition counseling sessions if assigned to treatment group
Exclusion Criteria:
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Currently diagnosed with an eating disorder
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Pregnant
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Current physical training profile (ie limitation)
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Pending deployment in next 5 months
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Pending retirement in next 5 months
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Pending permanent change of duty station in the next 5 months
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Currently has a pacemaker (contraindicated for bioelectrical impedance analysis)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
Sponsors and Collaborators
- Madigan Army Medical Center
- TriService Nursing Research Program
Investigators
- Principal Investigator: Mary S McCarthy, PhD, Madigan AMC
Study Documents (Full-Text)
None provided.More Information
Publications
- Bray MS, Loos RJ, McCaffery JM, Ling C, Franks PW, Weinstock GM, Snyder MP, Vassy JL, Agurs-Collins T; Conference Working Group. NIH working group report-using genomic information to guide weight management: From universal to precision treatment. Obesity (Silver Spring). 2016 Jan;24(1):14-22. doi: 10.1002/oby.21381. Review. Erratum in: Obesity (Silver Spring). 2016 Mar;24(3):757.
- Celis-Morales C, Livingstone KM, Marsaux CF, Forster H, O'Donovan CB, Woolhead C, Macready AL, Fallaize R, Navas-Carretero S, San-Cristobal R, Kolossa S, Hartwig K, Tsirigoti L, Lambrinou CP, Moschonis G, Godlewska M, Surwiłło A, Grimaldi K, Bouwman J, Daly EJ, Akujobi V, O'Riordan R, Hoonhout J, Claassen A, Hoeller U, Gundersen TE, Kaland SE, Matthews JN, Manios Y, Traczyk I, Drevon CA, Gibney ER, Brennan L, Walsh MC, Lovegrove JA, Alfredo Martinez J, Saris WH, Daniel H, Gibney M, Mathers JC. Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries. Genes Nutr. 2015 Jan;10(1):450. doi: 10.1007/s12263-014-0450-2. Epub 2014 Dec 10.
- Corella D, Coltell O, Mattingley G, Sorlí JV, Ordovas JM. Utilizing nutritional genomics to tailor diets for the prevention of cardiovascular disease: a guide for upcoming studies and implementations. Expert Rev Mol Diagn. 2017 May;17(5):495-513. doi: 10.1080/14737159.2017.1311208. Epub 2017 Apr 3. Review.
- de Toro-Martín J, Arsenault BJ, Després JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8). pii: E913. doi: 10.3390/nu9080913. Review.
- Povel CM, Boer JM, Onland-Moret NC, Dollé ME, Feskens EJ, van der Schouw YT. Single nucleotide polymorphisms (SNPs) involved in insulin resistance, weight regulation, lipid metabolism and inflammation in relation to metabolic syndrome: an epidemiological study. Cardiovasc Diabetol. 2012 Oct 29;11:133. doi: 10.1186/1475-2840-11-133.
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