Overview

This trial is active, not recruiting.

Conditions obese, nondiabetic
Treatment weight loss
Sponsor University of California, San Diego
Collaborator California Walnut Commission
Start date December 2011
End date July 2015
Trial size 234 participants
Trial identifier NCT01424007, 1U54CA155435-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet.
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)
Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet.
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)
Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet.
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 Outcomes

Measure
Weight loss
time frame: 1 year

Secondary Outcomes

Measure
Blood factors
time frame: 1 year
Nutrient-gene interactions
time frame: 1 year

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Principal investigator Cheryl Rock, PhD, RD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of California, San Diego.