Precision Nutrition Impact on Health-Related Behavior Change

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.

Conditions

• Metabolic Syndrome

Interventions

OTHER

Professional nutrition counseling

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

No professional nutrition 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.

Sponsors & Collaborators

• TriService Nursing Research Program

  collaborator OTHER

• Madigan Army Medical Center

  lead FED

Principal Investigators

• Mary S McCarthy, PhD · Madigan AMC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-20

Primary Completion

2021-07-09

Completion

2021-07-09

Countries

• United States

Study Locations