Substituting Mushrooms for Meat to Control Body Weight

Obesity Clinical Trial

Official title:

Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177085
• Other study ID #: Mush2
• Status: Completed
• Phase: N/A
• First received: November 5, 2008
• Last updated: March 30, 2018
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Mushroom Council

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-control efficacy		1 year
Primary	Weight-loss efficacy		6 months
Secondary	Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation		6 months