Precision Nutrition Impact on Health-Related Behavior Change

NCT04959318 | Completed

• 1 other identifier: 219081
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

nutrition; military; nutrigenomics

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Pounds lost between measurements

  12-14 weeks

Secondary Outcomes (7)

• Body fat

  12-14 weeks

• Waist circumference

  12-14 weeks

• Serum Cholesterol

  12-14 weeks

• Systolic blood pressure

  12-14 weeks

• Diastolic blood pressure

  12-14 weeks

Study Arms (2)

Treatment group or counseling group

EXPERIMENTAL

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

Control group or comparison group

ACTIVE COMPARATOR

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

Interventions

Professional nutrition counseling OTHER

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.

Also known as: Gene-based dietary counseling

Treatment group or counseling group

No professional nutrition counseling OTHER

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.

Also known as: Pamphlets

Control group or comparison group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active duty Army or Air Force
• Age 18-45
• Able to read and comprehend English
• Assigned to JBLM or JBSA-Lackland,
• Remaining on station for 5 months
• Consider self generally healthy
• History of or currently out of compliance with military fitness standards
• Willing to submit 2 blood samples including one for gene testing
• Willing to undergo 1 DEXA scan (JBLM only)
• Willing to participate in 6 weekly nutrition counseling sessions if assigned to treatment group

You may not qualify if:

• Currently diagnosed with an eating disorder
• Pregnant
• Current physical training profile (ie limitation)
• Pending deployment in next 5 months
• Pending retirement in next 5 months
• Pending permanent change of duty station in the next 5 months
• Currently has a pacemaker (contraindicated for bioelectrical impedance analysis)

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• TriService Nursing Research Program: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (8)

• 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.

  PMID: 26692578 BACKGROUND

• de Toro-Martin J, Arsenault BJ, Despres 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):913. doi: 10.3390/nu9080913.

  PMID: 28829397 BACKGROUND

• Liang Y, Kelemen A. Shared polymorphisms and modifiable behavior factors for myocardial infarction and high cholesterol in a retrospective population study. Medicine (Baltimore). 2017 Sep;96(37):e7683. doi: 10.1097/MD.0000000000007683.

  PMID: 28906356 BACKGROUND

• Povel CM, Boer JM, Onland-Moret NC, Dolle 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.

  PMID: 23101478 BACKGROUND

• Corella D, Coltell O, Mattingley G, Sorli 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.

  PMID: 28337931 BACKGROUND

• Joseph MS, Konerman MA, Zhang M, Wei B, Brinza E, Walden P, Jackson EA, Rubenfire M. Long-term outcomes following completion of a structured nutrition and exercise lifestyle intervention program for patients with metabolic syndrome. Diabetes Metab Syndr Obes. 2018 Nov 15;11:753-759. doi: 10.2147/DMSO.S175858. eCollection 2018.

  PMID: 30532575 BACKGROUND

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  PMID: 25491748 BACKGROUND

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  PMID: 25673413 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mary S McCarthy, PhD

  Madigan AMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician is external to the research team and has not been involved throughout the trial period. She will receive data upon completion of the trial and perform the outcomes assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Model Details: Subjects were enrolled, submitted fasting blood sample, and returned for initial measurements when lab results were available. At this visit, randomization based on a random number generator and concealed allocation with sequentially numbered opaque envelopes took place. This allowed the first treatment/professional counseling session to be held the same day depending on group assignment.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 13, 2021
• Study Start: November 20, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)