ObesityMush 1NCT00198770
Dietary Compensation With Substitution of Meat Products With White Button Mushrooms.
A study testing dietary substitution to assess level of caloric compensation in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- dietary substitution to assess level of caloric compensation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
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.
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.
Read the detailed description
- 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.
- 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.
- 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: n=40 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.
- Conditions
- Obesity
- Being tested
- dietary substitution to assess level of caloric compensation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary substitution to assess level of caloric compensationDietary supplement
Mushrooms substituted for meat in dishes
| Study group | Role | What they receive |
|---|---|---|
| Crossover design - 1 arm | Experimental | Meat week followed by mushroom week, counterbalanced order Receives: Dietary Supplement: dietary substitution to assess level of caloric compensation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake- by meal, by day separately for days 1-4, and by total intervention period (mushroom substituted vs. not)
Measured: 2 wks
Percent calorie and fat-gram compensation- again by meal, day, and period.
Measured: 2 wks
Secondary outcomes (2)
Satiety (VASs)- by meal, day, and period.
Measured: 2 wks
All outcomes will be analyzed for the total study population, and separately by gender and weight class.
Measured: 2 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Mushroom Council
- Responsible party
- Sponsor
- Investigators
- Lawrence J Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198770
- Sponsor's protocol ID
- MC2004-01
- Acronym
- Mush 1
- Status last verified
- Mar 2018
- First submitted
- 13 Sep 2005
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18221822
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00198770
- Acronym / sponsor ID
- Mush 1 / MC2004-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Mushroom Council
- Study start
- Mar 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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: n=40 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crossover design - 1 arm | Experimental | Dietary Supplement: dietary substitution to assess level of caloric compensationMeat week followed by mushroom week, counterbalanced order |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary substitution to assess level of caloric compensationMushrooms substituted for meat in dishes | Dietary supplement | Crossover design - 1 arm |
Primary outcome
Total energy intake- by meal, by day separately for days 1-4, and by total intervention period (mushroom substituted vs. not)
Time frame: 2 wks
Percent calorie and fat-gram compensation- again by meal, day, and period.
Time frame: 2 wks
2 secondary outcomes
Satiety (VASs)- by meal, day, and period.
Time frame: 2 wks
All outcomes will be analyzed for the total study population, and separately by gender and weight class.
Time frame: 2 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Background: PubMed 18221822Cheskin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary substitution to assess level of caloric compensation in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake- by meal, by day separately for days 1-4, and by total intervention period (mushroom substituted vs. not) (time frame: 2 wks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.