Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obese
- Sponsor
- University of California, San Diego
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Weight loss
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Cheryl Rock
Study Principal Investigator
University of California, San Diego
Eligibility 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
- •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
Outcomes
Primary Outcomes
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 Outcomes
- Blood factors(1 year)
- Nutrient-gene interactions(1 year)