Nutrigenomics: Personalizing Weight Loss for Obese Veterans

March 19, 2021 updated by: Amir Zarrinpar, MD, PhD, University of California, San Diego
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

About 35% of veterans are obese. The MOVE! program is a nation-wide 8-week program of group classes nationally to help obese veterans lose weight. While the program is successful for some veterans, about 75% of veterans are unable to lose ≥5% of their weight 24 weeks after MOVE! New methods are needed to help obese veterans seeking weight loss. Using personalized genomic information dictating a specific diet, and information on exercise and eating behaviors, may be one means to help promote weight loss. Just a single nucleotide change or polymorphism (SNP) in a gene can increase a person's risk for obesity, or change their lipid profile in response to the consumption of different macronutrients such as of fats or carbohydrates. Over 54 genetic loci have been associated with obesity phenotypes and clinical studies are now reporting associations between SNPs and/or functional alterations of gene expression (epigenetics) and the ability to lose weight or not. We will implement a randomized clinical trial to test a set of genomic data called the FIT™ test (Pathway Genomics™) containing information on SNPs that affect obesity risk, confer specific diet recommendations, outline eating behaviors and suggest responses to various exercise regimens. The overall goal of this project is to evaluate if this supplemental genetic information with a genomically-derived diet built around packaged meals to improve adherence, in parallel with the MOVE! program at the VA in San Diego, will promote weight loss in more obese veterans than those receiving usual care and eating diets based around packaged meals. Our primary hypotheses are that more obese veterans in the MOVE! program will lose 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 or 24 weeks. We also hypothesize that more veterans in the genomic group that lose 5% weight loss at 8 weeks will maintain this weight loss after 24 weeks compared to veterans in the usual care group.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Veterans able to receive care at the VASDHS and planning to start the MOVE! program.
  2. Veterans able to understand and consent to the study.
  3. BMI equal to or greater than 30 kg/m2.

Exclusion Criteria:

  1. Veterans unable to receive care at the VASDHS.
  2. Veterans unable to understand the consent process at the discretion of the PI.
  3. Active substance abuse or substance dependence disorder
  4. Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments
  5. Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG.
  6. Uncontrolled thyroid disease as measured by a TSH above or below the normal range.
  7. Body mass index < 30 kg/m2.
  8. Chronic kidney disease stage III or higher by National Kidney Foundation criteria (GFR = 30-59 ml/min).
  9. New York Heart Association's functional classification of congestive heart failure above Class I (not limited with normal physical activity by symptoms; Class II occurs when ordinary physical activity results in fatigue, dyspnea, or other symptoms).
  10. Sodium or potassium outside the normal range.
  11. Edema requiring the use of daily diuresis with furosemide, bumex or other diuretic (does not include hydrochlorthiazide).
  12. The use of high dose oral corticosteroids (above replacement doses).
  13. Veterans deficient in 25-OH vitamin D (<20 units/dl).
  14. Veterans with fasting LDL > 190 mg/dl.
  15. Veterans with fasting triglyceride levels > 1000 mg/dl.
  16. Excessive caffeine use (>6 caffeinated beverages/days).
  17. Prior gastrointestinal surgery with the exception of distal appendectomy.
  18. Acute infections or current use of antibiotic therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual Care
Usual care for veterans as part of the MOVE! program
Genetic: Usual Care
Patients receive the same dietary recommendation regardless of their genetic information
Other Names:
  • Standard dietary recommendations
Active Comparator: Personalized Genomics
Personalized genomics information from the FIT Test, Pathway Genomics
Genetic: Personalized Genomics
A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Other Names:
  • FIT test from Pathway Genomics, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Weight Loss of 5% or More at 8 Weeks
Time Frame: 8 weeks
Our primary hypotheses are that more obese veterans in the MOVE! program will lose greater or equal to 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 weeks.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Weight Loss of 5% or More at 24 Weeks
Time Frame: 24 weeks
We hypothesize that more veterans in the genomic group that lose greater or equal to 5% weight loss at 8 weeks will maintain this weight loss after 24 weeks compared to veterans in the usual care group.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VASDNUTRIMOVE13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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