Metabolism, Exercise and Nutrition at UCSD (MENU Study)

Not Applicable

Completed

• Conditions: Obese; Nondiabetic
• Interventions: Behavioral: Weight loss

• Registration Number: NCT01424007
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-26
• Study Start: 2011-12
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 245

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walnut-rich diet	Weight loss	Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet.
Lower fat diet	Weight loss	Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet.
Lower carbohydrate diet	Weight loss	Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet.

Primary Outcome Measures

Name	Time	Method
Weight loss	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

Name	Time	Method
Blood factors	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.
Nutrient-gene interactions	1 year	To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.

Trial Locations

Locations (1)

Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States