ObesityNCT01177085
Substituting Mushrooms for Meat to Control Body Weight
A study testing Weight-loss and weight-maintenance diets in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Weight-loss and weight-maintenance diets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male, female, >=18 years old
- Omnivorous
- BMI 25-40
- Seeking weight-loss
Who cannot join
- <18 years old
- Vegetarians
- Dislike mushroom
- Chronic disease
- HIV+
- Rheumatoid arthritis
- Pregnant or nursing child
- Must not self-report allergies to mushrooms
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: Substituting Mushrooms for Meat: A Controlled Clinical Trial 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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Weight-loss and weight-maintenance diets
- Keywords
- obesity, weight, weight-loss, mushroom, oxidative, stress, immune, function, inflammation
- Medical subject headings
- Obesity, Body Weight, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-loss and weight-maintenance dietsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mushroom | Experimental | Mushroom enriched weight loss diet. Participants will be given a personalized diet plan, 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. Receives: Behavioral: Weight-loss and weight-maintenance diets |
| No mushroom diet | Active comparator | Participants will be given a personalized diet plan, 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. Receives: Behavioral: Weight-loss and weight-maintenance diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-control efficacy
Measured: 1 year
Weight-loss efficacy
Measured: 6 months
Secondary outcomes (1)
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
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
- NCT01177085
- Sponsor's protocol ID
- Mush2
- Status last verified
- Mar 2018
- First submitted
- 5 Nov 2008
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight
- ClinicalTrials.gov ID
- NCT01177085
- Acronym / sponsor ID
- Mush2
- Conditions
- Obesity
- Keywords
- obesity, weight, weight-loss, mushroom, oxidative, stress, immune, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Mushroom Council
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Aug 2010 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mushroom | Experimental | Behavioral: Weight-loss and weight-maintenance dietsMushroom enriched weight loss diet. Participants will be given a personalized diet plan, 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. |
| No mushroom diet | Active comparator | Behavioral: Weight-loss and weight-maintenance dietsParticipants will be given a personalized diet plan, 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, female, >=18 years old
- Omnivorous
- BMI 25-40
- Seeking weight-loss
Key exclusion criteria (8 listed)
- <18 years old
- Vegetarians
- Dislike mushroom
- Chronic disease
- HIV+
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 |
|---|---|---|
| Weight-loss and weight-maintenance dietsParticipants 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. | Behavioural | Mushroom, No mushroom diet |
Primary outcome
Weight-control efficacy
Time frame: 1 year
Weight-loss efficacy
Time frame: 6 months
1 secondary outcome
Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation
Time frame: 6 months
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 Weight-loss and weight-maintenance diets 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 4 inclusion and 8 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?
Weight-control efficacy (time frame: 1 year). 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 NCT01177085, 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.