Precision Nutrition Impact on Health-Related Behavior Change
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

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.
    

Intervention name(s): Professional nutrition counseling; No professional nutrition counseling
Intervention type(s): Other; Other
Intervention description(s): 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.; 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 intervention name(s): Gene-based dietary counseling; Pamphlets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: nutrition; military; nutrigenomics