Nutrigenomics: Personalizing Weight Loss for Obese Veterans

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Karen L. Herbst, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01859403
First received: May 17, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.


Condition Intervention
Obesity
Genetic: Personalized Genomics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutrigenomics: Personalizing Weight Loss for Obese Veterans

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 5% weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 5% weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Care
Usual care for veterans as part of the MOVE! program
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 Name: FIT test from Pathway Genomics, Inc.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859403

Contacts
Contact: Karen L Herbst, PhD, MD 858-552-8585 ext 7384 karen.herbst@va.gov
Contact: Amir Zarrinpar, MD 858-442-1359 azarrinpar@ucsd.edu

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Karen L Herbst, PhD, MD    858-552-8585 ext 7384    karen.herbst@va.gov   
Contact: Amir Zarrinpar, MD    858-442-1359    azarrinpar@ucsd.edu   
Principal Investigator: Karen L Herbst, PhD, MD         
Sub-Investigator: Amir Zarrinpar, MD         
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Karen L. Herbst, Principal Invesigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01859403     History of Changes
Other Study ID Numbers: VASDNUTRIMOVE13
Study First Received: May 17, 2013
Last Updated: May 17, 2013
Health Authority: United States: UCSD Human Research Protection Program

Keywords provided by University of California, San Diego:
veteran
obesity
personalized genomics

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014