Substituting Mushrooms for Meat to Control Body Weight

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Weight-loss and weight-maintenance diets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mushroom<br>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<br>* 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.<br>|
| Active Comparator: No mushroom diet<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-control efficacy |  | 1 year | 
| Weight-loss efficacy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight, weight-loss, mushroom, oxidative, stress, immune, function, inflammation