Metabolism, Exercise and Nutrition at UCSD (MENU Study)
This study is currently recruiting participants.
Verified December 2011 by University of California, San Diego
Sponsor:
University of California, San Diego
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01424007
First received: August 24, 2011
Last updated: December 30, 2011
Last verified: December 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat [MUFA] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.
| Condition | Intervention |
|---|---|
|
Obese Nondiabetic |
Behavioral: Weight loss |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]Weight loss response, depending on insulin status, to diets that differ in macronutrient composition: 1) higher carbohydrate and lower fat, 2) lower carbohydrate and higher monounsaturated fat [MUFA] or 3) lower carbohydrate and walnut-rich higher fat
Secondary Outcome Measures:
- Blood factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]To examine whether there is a differential response, depending on insulin resistance status, dietary macronutrient composition and weight loss in hormonal factors and markers of inflammation.
- Nutrient-gene interactions [ Time Frame: 1 year ] [ Designated as safety issue: No ]To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.
| Estimated Enrollment: | 234 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lower fat diet
Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet.
|
Behavioral: Weight loss
Participants would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
|
|
Experimental: Lower carbohydrate diet
Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet.
|
Behavioral: Weight loss
Participants would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
|
|
Experimental: Walnut-rich diet
Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet.
|
Behavioral: Weight loss
Participants would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged 21 years and older
- Have BMI >30.0 kg/m2 and <40 kg/m2
- Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
- Able to provide data through questionnaires and by telephone
- Willing to maintain contact with the investigators for 12 months
- Willing to allow blood collections
- No known allergy to tree nuts
- Able to be physically active
Exclusion Criteria:
- Diabetic
- Inability to be moderately physically active
- A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
- Currently pregnant/breastfeeding
- Planning to become pregnant within the next year
- Currently enrolled in a weight loss program or diet intervention study
- Current use of weight loss medication or supplements
- Planned surgical procedure that can impact the conduct of the study
- Have plans to relocate from area within the next year
- 6+ months use of meds likely to cause weight gain or prevent weight loss
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424007
Contacts
| Contact: Elizabeth Quintana, MS, RD | 858-822-6162 | elquintana@ucsd.edu |
Locations
| United States, California | |
| Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093-0901 | |
| Contact: Elizabeth Quintana, MS, RD 858-822-6162 elquintana@ucsd.edu | |
| Principal Investigator: Cheryl Rock, PhD, RD | |
Sponsors and Collaborators
University of California, San Diego
California Walnut Commission
Investigators
| Principal Investigator: | Cheryl Rock, PhD, RD | University of California, San Diego |
More Information
No publications provided
| Responsible Party: | Cheryl Rock, Study Principal Investigator, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01424007 History of Changes |
| Other Study ID Numbers: | 1U54CA155435-1 |
| Study First Received: | August 24, 2011 |
| Last Updated: | December 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Obese Women Weight loss Exercise |
Physical activity Diet Female |
ClinicalTrials.gov processed this record on May 23, 2013