Nutrigenomics: Personalizing Weight Loss for Obese Veterans

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.

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.