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Substituting Mushrooms for Meat to Control Body Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177085
First Posted: August 6, 2010
Last Update Posted: December 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mushroom Council
Information provided by:
Johns Hopkins Bloomberg School of Public Health
  Purpose
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.

Condition Intervention
Obesity Behavioral: Weight-loss and weight-maintenance diets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Weight-control efficacy [ Time Frame: 1 year ]
  • Weight-loss efficacy [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation [ Time Frame: 6 months ]

Estimated Enrollment: 100
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Weight-loss and weight-maintenance diets
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.
Behavioral: Weight-loss and weight-maintenance diets
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177085


Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Mushroom Council
Investigators
Principal Investigator: Lawrence J Cheskin, MD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:
Responsible Party: Lawrence J. Cheskin, MD, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01177085     History of Changes
Other Study ID Numbers: Mush2
First Submitted: November 5, 2008
First Posted: August 6, 2010
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
obesity
weight
weight-loss
mushroom
oxidative
stress
immune
function
inflammation

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms