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Substituting Mushrooms for Meat to Control Body Weight

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight-loss and weight-maintenance diets
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight, weight-loss, mushroom, oxidative, stress, immune, function, inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mushroom

No mushroom diet

Arm Description

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, 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.

Outcomes

Primary Outcome Measures

Weight-control efficacy
Weight-loss efficacy

Secondary Outcome Measures

Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation

Full Information

First Posted
November 5, 2008
Last Updated
March 30, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Mushroom Council
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1. Study Identification

Unique Protocol Identification Number
NCT01177085
Brief Title
Substituting Mushrooms for Meat to Control Body Weight
Official Title
Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Mushroom Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, weight, weight-loss, mushroom, oxidative, stress, immune, function, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mushroom
Arm Type
Experimental
Arm Description
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.
Arm Title
No mushroom diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight-loss and weight-maintenance diets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight-control efficacy
Time Frame
1 year
Title
Weight-loss efficacy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence J Cheskin, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18221822
Citation
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.
Results Reference
background

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Substituting Mushrooms for Meat to Control Body Weight

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