Nondiabetic, Obese
Conditions
Keywords
Obese, Women, Weight loss, Exercise, Physical activity, Diet, Female
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.
Interventions
BEHAVIORALWeight 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.
Sponsors
California Walnut Commission
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed