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Completed

NCT Number: NCT04959318

Precision Nutrition Impact on Health-Related Behavior Change

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: Gene-based dietary counseling

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.

Other names: Pamphlets

Primary outcomes

  1. Weight loss

    Time frame: 12-14 weeks

    Pounds lost between measurements

Secondary outcomes

  1. Body fat

    Time frame: 12-14 weeks

    Percent change in body fat over time

  2. Waist circumference

    Time frame: 12-14 weeks

    Change in waist circumference measured in inches to reduce risk for MetS over time

  3. Serum Cholesterol

    Time frame: 12-14 weeks

    Blood level of serum cholesterol to reduce risk for MetS over time

  4. Systolic blood pressure

    Time frame: 12-14 weeks

    Change in systolic blood pressure to reduce risk for MetS over time

  5. Diastolic blood pressure

    Time frame: 12-14 weeks

    Change in diastolic blood pressure to reduce risk for MetS over time

  6. Serum glucose

    Time frame: 12-14 weeks

    Change in blood glucose level to reduce risk for MetS over time

  7. Serum triglyceride

    Time frame: 12 -14 weeks

    Change in blood triglyceride level to reduce risk for MetS over time

Sponsors and collaborators

Lead sponsor

Madigan Army Medical Center

Fed

Collaborators

  • TriService Nursing Research Program

Registry information

Official study title

Precision Nutrition Impact on Health-Related Behavior Change in Active Duty Service Members

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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