Metabolism, Exercise and Nutrition at UCSD (MENU Study)

University of California San Diego

Status: Completed

Conditions: Nondiabetic; Obese

Treatments: Behavioral: Weight loss

Study type: Interventional

Funder types: Other

Identifiers

NCT01424007

1U54CA155435-1

1U54CA155435 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 3 patient groups

Lower fat diet

Experimental group

Description:

Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet.

Treatment:

Behavioral: Weight loss

Lower carbohydrate diet

Experimental group

Description:

Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet.

Treatment:

Behavioral: Weight loss

Walnut-rich diet

Experimental group

Description:

Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet.

Treatment:

Behavioral: Weight loss