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NCT Number: NCT01177085

Substituting Mushrooms for Meat to Control Body Weight

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight-loss and weight-maintenance diets

Behavioral

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 outcomes

  1. Weight-control efficacy

    Time frame: 1 year

  2. Weight-loss efficacy

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Mushroom Council

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2010
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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