Metabolism, Exercise and Nutrition at UCSD (MENU Study)

This study is ongoing, but not recruiting participants.
Sponsor:
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: July 7, 2014
Last verified: July 2014
  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
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: NCT01424007

Locations
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0901
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: July 7, 2014
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 September 30, 2014