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

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ClinicalTrials.gov Identifier: NCT01424007
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Cheryl Rock, University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment Phase
Obese Nondiabetic Behavioral: Weight loss Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Study Start Date : December 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
1U54CA155435 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: April 2016

Keywords provided by Cheryl Rock, University of California, San Diego:
Obese
Women
Weight loss
Exercise
Physical activity
Diet
Female