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OpenTrials
Completed

NCT Number: NCT01424007

Metabolism, Exercise and Nutrition at UCSD (MENU Study)

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.

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Key information

Conditions

Obese Behavior Body Weight Body Weight Changes Motor Activity Nondiabetic Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moores UCSD Cancer Center

La Jolla, California, 92093-0901, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss

Behavioral

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.

Primary outcomes

  1. 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

  1. Blood factors

    Time frame: 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.

  2. Nutrient-gene interactions

    Time frame: 1 year

    To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • California Walnut Commission

Registry information

Official study title

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

Acronym: MENU

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2011
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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