Metabolism, Exercise and Nutrition at UCSD (MENU Study)
MENU
Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
2 other identifiers
interventional
245
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 5, 2019
July 1, 2019
4.6 years
August 24, 2011
July 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Blood factors
1 year
Nutrient-gene interactions
1 year
Study Arms (3)
Lower fat diet
EXPERIMENTALParticipants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet.
Lower carbohydrate diet
EXPERIMENTALParticipants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet.
Walnut-rich diet
EXPERIMENTALParticipants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- + months use of meds likely to cause weight gain or prevent weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- California Walnut Commissioncollaborator
Study Sites (1)
Moores UCSD Cancer Center
La Jolla, California, 92093-0901, United States
Related Publications (3)
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.
PMID: 27733248RESULTLe 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.
PMID: 26811166RESULTDonnan 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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Rock, PhD, RD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
July 5, 2019
Record last verified: 2019-07