Metabolism, Exercise and Nutrition at UCSD (MENU Study) (MENU)

July 1, 2019 updated by: Cheryl Rock, University of California, San Diego

Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0901
        • Moores UCSD Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 1 year
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood factors
Time Frame: 1 year
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.
1 year
Nutrient-gene interactions
Time Frame: 1 year
To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

California Walnut Commission

Investigators

  • Principal Investigator: Cheryl Rock, PhD, RD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (ESTIMATE)

August 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1U54CA155435-1
  • 1U54CA155435 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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