Metabolism, Exercise and Nutrition at UCSD (MENU Study)

Obese Clinical Trial

— MENU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424007
• Other study ID #: 1U54CA155435-1
• Secondary ID: 1U54CA155435
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: September 2016

Study information

• Verified date: July 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nondiabetic
• Obese

Intervention

Behavioral:
• Weight 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.

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	California Walnut Commission

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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). pii: e002771. doi: — View 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. Metab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Nutrient-gene interactions	To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.	1 year