Clinical trial NCT01424007: Metabolism, Exercise and Nutrition at UCSD (MENU Study)
Official title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Nondiabetic
Keywords: Obese
Women
Weight loss
Exercise
Physical activity
Diet
Female
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: California Walnut Commission
First posted: 2011-08-26
Enrollment: 245
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

* 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

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Blood factors
timeFrame: 1 year
measure: Nutrient-gene interactions
timeFrame: 1 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Cheryl Rock, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rock CL, Flatt SW, Pakiz B, Quintana EL, Heath DD, Rana BK, Natarajan L. Effects of diet composition on weight loss, metabolic factors and biomarkers in a 1-year weight loss intervention in obese women examined by baseline insulin resistance status. Metabolism. 2016 Nov;65(11):1605-1613. doi: 10.1016/j.metabol.2016.07.008. Epub 2016 Jul 25.
citation: Le T, Flatt SW, Natarajan L, Pakiz B, Quintana EL, Heath DD, Rana BK, Rock CL. Effects of Diet Composition and Insulin Resistance Status on Plasma Lipid Levels in a Weight Loss Intervention in Women. J Am Heart Assoc. 2016 Jan 25;5(1):e002771. doi: 10.1161/JAHA.115.002771.
citation: Donnan MS, Heath DD, Flatt SW, Pakiz B, Quintana EL, Rana BK, Natarajan L and Rock CL. Factors Associated with Tocopherol Status in Obese Women: Effects of Diet Composition and Weight Loss. Vitam & Miner, 5(3): 147. doi: 10.4172/2376-1318.1000147, 2016.