ObesityNCT01859403
Nutrigenomics: Personalizing Weight Loss for Obese Veterans
A study testing Personalized Genomics in people with Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Personalized Genomics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans able to receive care at the VASDHS and planning to start the MOVE! program.
- Veterans able to understand and consent to the study.
- BMI equal to or greater than 30 kg/m2.
Who cannot join
- Veterans unable to receive care at the VASDHS.
- Veterans unable to understand the consent process at the discretion of the PI.
- Active substance abuse or substance dependence disorder
- Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments
- Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG.
- Uncontrolled thyroid disease as measured by a TSH above or below the normal range.
Show all 18Show fewer
- Body mass index < 30 kg/m2.
- Chronic kidney disease stage III or higher by National Kidney Foundation criteria (GFR = 30-59 ml/min).
- 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).
- Sodium or potassium outside the normal range.
- Edema requiring the use of daily diuresis with furosemide, bumex or other diuretic (does not include hydrochlorthiazide).
- The use of high dose oral corticosteroids (above replacement doses).
- Veterans deficient in 25-OH vitamin D (<20 units/dl).
- Veterans with fasting LDL > 190 mg/dl.
- Veterans with fasting triglyceride levels > 1000 mg/dl.
- Excessive caffeine use (>6 caffeinated beverages/days).
- Prior gastrointestinal surgery with the exception of distal appendectomy.
- Acute infections or current use of antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.
Read the 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.
- Conditions
- Obesity
- Being tested
- Personalized Genomics, Usual Care
- Keywords
- veteran, obesity, personalized genomics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized GenomicsGenetic
Also called FIT test from Pathway Genomics, Inc.
A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Usual CareGenetic
Also called Standard dietary recommendations
Patients receive the same dietary recommendation regardless of their genetic information
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Usual care for veterans as part of the MOVE! program Receives: Genetic: Usual Care |
| Personalized Genomics | Active comparator | Personalized genomics information from the FIT Test, Pathway Genomics Receives: Genetic: Personalized Genomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Weight Loss of 5% or More at 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.
Measured: 8 weeks
Secondary outcomes (1)
Number of Participants With Weight Loss of 5% or More at 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Zarrinpar, MD, PhD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859403
- Sponsor's protocol ID
- VASDNUTRIMOVE13
- Status last verified
- Mar 2021
- First submitted
- 17 May 2013
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Frankwich KA, Egnatios J, Kenyon ML, Rutledge TR, Liao PS, Gupta S, Herbst KL, Zarrinpar A. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1625-1632.e1. doi: 10.1016/j.cgh.2015.02.044. Epub 2015 Mar 10.
PubMed 25769412
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrigenomics: Personalizing Weight Loss for Obese Veterans
- ClinicalTrials.gov ID
- NCT01859403
- Acronym / sponsor ID
- VASDNUTRIMOVE13
- Conditions
- Obesity
- Keywords
- veteran, obesity, personalized genomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Genetic: Usual CareUsual care for veterans as part of the MOVE! program |
| Personalized Genomics | Active comparator | Genetic: Personalized GenomicsPersonalized genomics information from the FIT Test, Pathway Genomics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans able to receive care at the VASDHS and planning to start the MOVE! program.
- Veterans able to understand and consent to the study.
- BMI equal to or greater than 30 kg/m2.
Key exclusion criteria (18 listed)
- Veterans unable to receive care at the VASDHS.
- Veterans unable to understand the consent process at the discretion of the PI.
- Active substance abuse or substance dependence disorder
- Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments
- Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized GenomicsAlso: FIT test from Pathway Genomics, Inc.A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise | Genetic | Personalized Genomics |
| Usual CareAlso: Standard dietary recommendationsPatients receive the same dietary recommendation regardless of their genetic information | Genetic | Usual Care |
Primary outcome
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.
1 secondary outcome
Number of Participants With Weight Loss of 5% or More at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25769412Frankwich KA, Egnatios J, Kenyon ML, Rutledge TR, Liao PS, Gupta S, Herbst KL, Zarrinpar A. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1625-1632.e1. doi: 10.1016/j.cgh.2015.02.044. Epub 2015 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Genomics in people with Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Weight Loss of 5% or More at 8 Weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.