Madigan Army Medical Center
Tacoma, Washington, 98431, United States
NCT Number: NCT04959318
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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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Tacoma, Washington, 98431, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 12-14 weeks
Pounds lost between measurements
Time frame: 12-14 weeks
Percent change in body fat over time
Time frame: 12-14 weeks
Change in waist circumference measured in inches to reduce risk for MetS over time
Time frame: 12-14 weeks
Blood level of serum cholesterol to reduce risk for MetS over time
Time frame: 12-14 weeks
Change in systolic blood pressure to reduce risk for MetS over time
Time frame: 12-14 weeks
Change in diastolic blood pressure to reduce risk for MetS over time
Time frame: 12-14 weeks
Change in blood glucose level to reduce risk for MetS over time
Time frame: 12 -14 weeks
Change in blood triglyceride level to reduce risk for MetS over time
Madigan Army Medical Center
Fed
Precision Nutrition Impact on Health-Related Behavior Change in Active Duty Service Members
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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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