Dietary Compensation With Substitution of Meat Products With White Button Mushrooms.

NCT00198770 | Completed

• 1 other identifier: MC2004-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Unfortunately, current methods of achieving weight control are disappointing. There is also a great deal of public confusion over what constitutes an appropriate diet for weight control; 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 potential meat substitute) that they are. Mushrooms may be a new "diet food," especially as a substitute for higher calorie and fat staples like meat. This study examines whether there is compensation for the potential calorie and fat savings of substituting mushrooms for meat in dishes over a 4-day period.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Total energy intake- by meal, by day separately for days 1-4, and by total intervention period (mushroom substituted vs. not)

  2 wks

• Percent calorie and fat-gram compensation- again by meal, day, and period.

  2 wks

Secondary Outcomes (2)

• Satiety (VASs)- by meal, day, and period.

  2 wks

• All outcomes will be analyzed for the total study population, and separately by gender and weight class.

  2 wks

Study Arms (1)

Crossover design - 1 arm

EXPERIMENTAL

Meat week followed by mushroom week, counterbalanced order

Dietary Supplement: dietary substitution to assess level of caloric compensation

Interventions

dietary substitution to assess level of caloric compensation DIETARY_SUPPLEMENT

Mushrooms substituted for meat in dishes

Crossover design - 1 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18-65 (for phase 3), Body Mass Index between 18-45; not using appetite-affecting medications unless on established and stable dose; not using weight loss drugs; willing and able to comply with the protocol requirements; willing and able to give informed consent.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Mushroom Council: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related 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.

  PMID: 18221822 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 3, 2018

Record last verified: 2018-03

Locations

US (1)