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Substituting Mushrooms for Meat to Control Body Weight

This study has been completed.
Sponsor:
Collaborator:
The Mushroom Council
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01177085
First received: November 5, 2008
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Weight-control efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Weight-loss efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
The 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
Study First Received: November 5, 2008
Last Updated: December 8, 2010
Health Authority: United States: Institutional Review Board

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
Obesity
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on May 19, 2013