Unfortunately, current methods of achieving weight control are disappointing. While some obese individuals are able to achieve lasting success, they constitute a minority of dieters, and the recidivism rate may be as high as 80-90% following initially successful weight loss. There is also a great deal of public confusion over what constitutes an appropriate diet for weight control; opinions from experts vary widely, and there is a paucity of carefully performed, randomized, controlled clinical treatment trials to evaluate the varying opinions.

Mushrooms are not widely appreciated as the nutritious, low calorie, low fat food (and ideal meat substitute) that they are. While there are over 2,000 edible varieties of mushroom known, only a handful have become important in the American diet: white button, brown, enoki, shiitake, maitake, and portabella- though morels and oyster varieties are growing in popularity. While mushrooms are typically lumped with vegetables, they are botanically classified as fungi. They provide significant amounts of a number of essential nutrients, including vitamin D, riboflavin, niacin, pantothenic acid, copper, selenium, as well as dietary fiber. They are also quite low in calories and sodium, and appear to contain a number of substances that may reduce the risk of cancer, boost the immune system, and reduce the risk of coronary heart disease. Considering the recent epidemic increase in obesity and deterioration in nutritional quality of the typical American’s diet, mushrooms can and should be considered as a new “diet food,” especially as a substitute for higher calorie and fat staples like meat.

Condition	Intervention
Obesity	Behavior: caloric compensation

Further Study Details: 

Primary Outcomes: Total energy intake- by meal, by day separately for days 1-4, and by total intervention period (mushroom substituted vs. not); Percent calorie and fat-gram compensation- again by meal, day, and period.
Secondary Outcomes: Satiety (VASs)- by meal, day, and period.; Diet satisfaction- by meal and period.; All outcomes will be analyzed for the total study population, and separately by gender and weight class.
Expected Total Enrollment:  60

1. Development of suitable mushroom-meat substitutions. In this phase, expected to last 2 months, guided by information gathered from test subjects (see 2. below) we will devise and internally taste-test 7 or more test meals that entail mushroom substitutions that result in potential energy savings of at least 125 kcal per meal.

2. Study the palatability, consumer acceptance, and satiating properties of each mushroom-substituted meal using a panel of obese and normal weight men, women, seniors, and teenagers.

   In this phase, expected to last 3 months, panels of 5-10 individuals in each of the above categories will be recruited. Each panel will undergo structured interviews to determine preferences with respect to the substitutions being developed, and later taste tests using the meals developed. Once the best test meals have been chosen, satiety testing will occur as follows: Substituted and unsubstituted meals will be administered on separate days in random order in a single-blind fashion. 100-mm visual analog scales (VAS), anchored by extremes of hunger and satiety, desire for food, and thirst, will be administered before and at 30 minute intervals following consumption of the test meal, for a total of 5 hours. Students’ t-tests will be used to compare satiety scores between groups and meals.

3. Test in a controlled fashion the percent compensation over a 4-day period for the calorie and fat deficit that results when these mushroom-substituted meals are consumed compared with unsubstituted meals among obese and normal weight adults.

In this phase, expected to last 5 months, the following two hypotheses will be tested:

Hyp 1. Use of white button mushrooms as a substitute for meat at a single meal will result in significant reduction in total daily energy intake during the same 24 h period.

Hyp 2. The amount of calories and fat grams compensated for will be significantly less than 100% when the substitution of mushrooms for meat is continued on a one-meal daily basis for a period of 4 days.

Summary of experimental design: Controlled intervention study, crossover design with each subject serving as his or her own control. Subjects: n=40 healthy men and women, aged 18-65, stratified by BMI into 2 groups: BMI 18-25 kg/m2, and BMI 30-45 kg/m2, recruited by advertisement, screened for willingness to eat mushrooms and other test foods, and paid for their time.

Intervention: 11-day feeding study divided into two, 4-day intervention periods (Mondays through Thursdays), separated by a 3-day washout period (Friday through Sunday); subjects fed a standard breakfast and lunch meal on site, and precise food records gathered for dinner and any snacks taken off-site. One of the two 4-day intervention periods will include one meal per day that substitutes one of the 7 mushroom meals devised in phases 1 and 2 in place of meat meals, while the other 4-day intervention period will be the same except for not having any substituted meals. The order of the interventions will be randomized to eliminate order effects (i.e., half the subjects will start with the 4-days of mushroom substitutions, the other half will start with the 4 days of meat meals). Satiety measures will be obtained as in experiment #3, as well as measures of diet satisfaction. Weight will be measured on Mondays and Fridays.

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Ages 12 and over (for phase 2); ages 18-65 (for phase 3), Body Mass Index between 18-45— where BMI 18-24 is considered lean and BMI 25-45 is defined as overweight; not using appetite-affecting medications (e.g., Prozac or other SSRIs, synthroid, steroids) unless on established and stable dose; not using weight loss drugs (phentermine, sibutramine, orlistat, e.g.); willing and able to comply with the protocol requirements; willing and able to give informed consent; have a regular source of health care and permission of primary care provider

Exclusion Criteria:

Those participants that: have a strong dislike of the foods that may be involved; have a mold allergy/food allergy; have chronic, uncontrolled health problems (not including obesity and diabetes); have an autoimmune disorder (such as rheumatoid arthritis or SLE); have bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or have an uncontrolled psychiatric disorder (major depression, bipolar disorder, etc as determined at screening); are breast-feeding or pregnant at screening by urine pregnancy test.

Please refer to this study by ClinicalTrials.gov identifier  NCT00198770

Lawrence J Cheskin, MD      410.593.2860    cheskin@jhmi.edu
Amy M Mitchell, MS      410.502.3099    amitchel@jhmi.edu

Maryland
      Johns Hopkins Bloomberg School of Public Health, Baltimore,  Maryland,  21205,  United States

Study chairs or principal investigators

Lawrence J Cheskin, MD,  Principal Investigator,  Johns Hopkins Bloomberg School of Public Health   

Study ID Numbers:  MC2004-01
Last Updated:  September 19, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00198770
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-20