Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198770
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2005-09-13
Brief Title:
Dietary Compensation With Substitution of Meat Products With White Button Mushrooms
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Does Substitution of Meat Products With White Button Mushrooms Have Potential for Weight Reduction Studies of the Level of Short and Intermediate-term Caloric Compensation Satiety and Dietary Satisfaction Among Lean and Obese Men and Women
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mush 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
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
Detailed Description:
1 Development of suitable mushroom-meat substitutions In this phase guided by information gathered from test subjects see 2 below we will devise and internally taste-test 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
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 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 n40 healthy men and women aged 18-65 stratified by BMI 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 lunch meal on site and precise food records gathered for any meals or 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 Satiety measures will be obtained as in experiment 3 as well as measures of diet satisfaction Weight will be measured
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
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 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 n40 healthy men and women aged 18-65 stratified by BMI 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 lunch meal on site and precise food records gathered for any meals or 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 Satiety measures will be obtained as in experiment 3 as well as measures of diet satisfaction Weight will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None