Precision Nutrition Impact on Health-Related Behavior Change

Madigan Army Medical Center

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Professional nutrition counseling; Other: No professional nutrition counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04959318

219081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Treatment group or counseling group

Experimental group

Description:

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.

Treatment:

Other: Professional nutrition counseling

Control group or comparison group

Active Comparator group

Description:

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.

Treatment:

Other: No professional nutrition counseling