Precision Nutrition Impact on Health-Related Behavior Change
- Conditions
- Metabolic Syndrome
- Registration Number
- NCT04959318
- Lead Sponsor
- Madigan Army Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight loss 12-14 weeks Pounds lost between measurements
- Secondary Outcome Measures
Name Time Method Diastolic blood pressure 12-14 weeks Change in diastolic blood pressure to reduce risk for MetS 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
Serum glucose 12-14 weeks Change in blood glucose level to reduce risk for MetS over time
Body fat 12-14 weeks Percent change in body fat over time
Serum triglyceride 12 -14 weeks Change in blood triglyceride level to reduce risk for MetS over time
Trial Locations
- Locations (1)
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Madigan Army Medical Center🇺🇸Tacoma, Washington, United States