- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177085
Substituting Mushrooms for Meat to Control Body Weight
March 30, 2018 updated by: Johns Hopkins Bloomberg School of Public Health
Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight
This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical parameters following a weight-control diet using either standard food guide pyramid alone, or standard food guide pyramid with substitution of mushrooms for meat.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This intervention study has a primary aim to assess omnivorous adult males and females' ability to control their weight over a period of 1 year.
The control group will be required to use 90% lean ground beef a few times per week for one year while maintaining their personalized diet plans.
The experimental group will have to follow their personalized diets as well, but will be required to substitute mushrooms for meat at least three times per week.
Biochemical measures will also be assessed in response to the diet and weight loss.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Bloomberg School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male, female, >=18 years old
- Omnivorous
- BMI 25-40
- Seeking weight-loss
Exclusion Criteria:
- <18 years old
- Vegetarians
- Dislike mushroom
- Chronic disease
- HIV+
- Rheumatoid arthritis
- Pregnant or nursing child
- Must not self-report allergies to mushrooms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mushroom
Mushroom enriched weight loss diet.
Participants will be given a personalized diet plan, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
|
Participants will be given a personalized diet plan, with or without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
|
Active Comparator: No mushroom diet
Participants will be given a personalized diet plan, without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
|
Participants will be given a personalized diet plan, with or without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight-control efficacy
Time Frame: 1 year
|
1 year
|
Weight-loss efficacy
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lawrence J Cheskin, MD, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 5, 2008
First Submitted That Met QC Criteria
August 5, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Actual)
April 3, 2018
Last Update Submitted That Met QC Criteria
March 30, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mush2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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