Metabolism, Exercise and Nutrition at UCSD (MENU Study)

Study Overview
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Brief Summary
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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.

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

Conditions
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Obese, Nondiabetic

Intervention / Treatment
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* Behavioral: Weight loss


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower fat diet<br>Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet. | Behavioral: Weight loss<br>* 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.<br>|
| Experimental: Lower carbohydrate diet<br>Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet. | Behavioral: Weight loss<br>* 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.<br>|
| Experimental: Walnut-rich diet<br>Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet. | Behavioral: Weight loss<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Women, Weight loss, Exercise, Physical activity, Diet, Female