ObeseMENUNCT01424007
Metabolism, Exercise and Nutrition at UCSD (MENU Study)
A study testing Weight loss in people with Obese and Nondiabetic, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese, Nondiabetic
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093-0901
About this study
Official title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
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.
- Conditions
- Obese, Nondiabetic
- Being tested
- Weight loss
- Keywords
- Obese, Women, Weight loss, Exercise, Physical activity, Diet, Female
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lower fat diet | Experimental | Participants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet. Receives: Behavioral: Weight loss |
| Lower carbohydrate diet | Experimental | Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet. Receives: Behavioral: Weight loss |
| Walnut-rich diet | Experimental | Participants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet. Receives: Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
Nutrient-gene interactions
To identify nutrient-gene interactions that contribute to differential response of cytokines to weight loss and diet composition.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Cheryl Rock, University of California, San Diego
- Investigators
- Cheryl Rock, PhD, RD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424007
- Sponsor's protocol ID
- 1U54CA155435-1
- Other IDs
- 1U54CA155435
- Acronym
- MENU
- Status last verified
- Jul 2019
- First submitted
- 24 Aug 2011
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27733248Le 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.
PubMed 26811166Donnan 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
- ClinicalTrials.gov ID
- NCT01424007
- Acronym / sponsor ID
- MENU / 1U54CA155435-1
- Conditions
- Obese, Nondiabetic
- Keywords
- Obese, Women, Weight loss, Exercise, Physical activity, Diet, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- Dec 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower fat diet | Experimental | Behavioral: Weight lossParticipants in this group will be individually counseled and receive print materials on a higher-carbohydrate, lower-fat diet. |
| Lower carbohydrate diet | Experimental | Behavioral: Weight lossParticipants in this group will be individually counseled and receive print materials on a lower-carbohydrate, higher-monounsaturated fat diet. |
| Walnut-rich diet | Experimental | Behavioral: Weight lossParticipants in this group will be individually counseled and receive print materials on a lower-carbohydrate, walnut-rich higher-fat diet. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossParticipants 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. | Behavioural | Lower carbohydrate diet, Lower fat diet, Walnut-rich diet |
Primary outcome
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
2 secondary outcomes
Blood factors
Time frame: 1 year
Nutrient-gene interactions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Results publication: PubMed 27733248Rock 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.
- Results publication: PubMed 26811166Le 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.
- Results publicationDonnan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Rock, PhD, RD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss in people with Obese and Nondiabetic, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424007, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.