Substituting Mushrooms for Meat to Control Body Weight
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started May 2009
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
November 5, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 3, 2018
March 1, 2018
1.6 years
November 5, 2008
March 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight-control efficacy
1 year
Weight-loss efficacy
6 months
Secondary Outcomes (1)
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
6 months
Study Arms (2)
Mushroom
EXPERIMENTALMushroom 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.
No mushroom diet
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male, female, \>=18 years old
- Omnivorous
- BMI 25-40
- Seeking weight-loss
You may not qualify if:
- \<18 years old
- Vegetarians
- Dislike mushroom
- Chronic disease
- HIV+
- Rheumatoid arthritis
- Pregnant or nursing child
- Must not self-report allergies to mushrooms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Bloomberg School of Public Healthlead
- Mushroom Councilcollaborator
Study Sites (1)
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
Related Publications (1)
Cheskin LJ, Davis LM, Lipsky LM, Mitola AH, Lycan T, Mitchell V, Mickle B, Adkins E. Lack of energy compensation over 4 days when white button mushrooms are substituted for beef. Appetite. 2008 Jul;51(1):50-7. doi: 10.1016/j.appet.2007.11.007. Epub 2007 Dec 3.
PMID: 18221822BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence J Cheskin, MD
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2008
First Posted
August 6, 2010
Study Start
May 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 3, 2018
Record last verified: 2018-03