Substituting Mushrooms for Meat to Control Body Weight

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Weight-loss and weight-maintenance diets

• Registration Number: NCT01177085
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Study Timeline

• Study First Submitted: 2008-11-05
• Study Start: 2009-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mushroom	Weight-loss and weight-maintenance diets	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.
No mushroom diet	Weight-loss and weight-maintenance diets	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.

Primary Outcome Measures

Name	Time	Method
Weight-control efficacy	1 year
Weight-loss efficacy	6 months

Secondary Outcome Measures

Name	Time	Method
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation	6 months

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States