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Behavioural Intervention
CLEAN-MED Diet for Healthy Gut Microbiome
N/A
Recruiting
Led By Karen M Frank, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-60, at the time of consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks (short term) 12 months (long term)
Awards & highlights
Study Summary
This trial is testing how a switch to a healthy diet affects the environment in the intestine.
Who is the study for?
Healthy adults aged 18-60 who currently follow a Western diet and are willing to switch to a Mediterranean-like unprocessed foods diet (CLEAN-MED) for the study. They must be able to attend clinic visits, provide blood and stool samples, have internet access, and not have any severe health conditions or recent significant weight changes.Check my eligibility
What is being tested?
The trial is testing how changing from a traditional Western diet to a CLEAN-MED diet affects gut microbiome in healthy adults. Participants will either adopt the CLEAN-MED diet short-term (8 weeks) with provided food or long-term (up to 12 months), logging their intake and providing regular biological samples.See study design
What are the potential side effects?
Since this is a dietary intervention study focusing on healthy eating patterns, no significant side effects are expected. However, participants may experience changes in digestion or energy levels as they adjust to new diets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks (short term) 12 months (long term)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks (short term) 12 months (long term)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective is to assess changes in gut microbiome associated with a Mediterranean-like and unprocessed food diet compared to a habitual Western diet in healthy adults.
Secondary outcome measures
Identify associations between Mediterranean-like unprocessed food diet adherence with perceived quality of life.
Measure biomarkers in various bodily specimens (stool, blood, etc.) using the pertinent biochemical assays.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Short-term, Western Diet, low MedDiet score a Intervention: WeExperimental Treatment1 Intervention
Study arm will consume a Mediterranean like diet, while tracking their food intake for 9 weeks. With low MEdDIet score.
Group II: Short-term, Western Diet, low MedDiet score a Intervention: CLExperimental Treatment1 Intervention
Study arm will consume a western diet eating as they normally would for 9 weeks. With low MEdDIet score.
Group III: Short-term, Western Diet, high MedDiet score a Intervention: WExperimental Treatment1 Intervention
Study arm will consume a Mediterranean like diet, while tracking their food intake for 9 weeks, With high MEdDIet score.
Group IV: Short-term, Western Diet, high MedDiet score a Intervention: CExperimental Treatment1 Intervention
Study arm will consume a Mediterranean like diet, while tracking their food intake for 9 weeks, With high MEdDIet score.
Group V: Long-term a Intervention: CLEAN-MEDExperimental Treatment1 Intervention
Study arm will consume a Mediterranean like diet, while tracking their food intake for 12 months
Find a Location
Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
880,002 Total Patients Enrolled
Karen M Frank, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
2 Previous Clinical Trials
521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have painful gallstones.I am currently taking certain medications.I have not had heart disease or conditions in the last year.My kidney function is low (eGFR under 50).I can prepare and eat fresh meals.I have diabetes or a history of gestational diabetes, or I am on medication for low blood sugar.I am not fluent in English.I have taken specific medications in the last 2 months.My gender, race, or ethnicity does not limit my participation.I can travel to the clinic for visits.I have not used weight or appetite control supplements, including laxatives, in the last 4 weeks.I weigh less than 100 lbs.I have taken probiotic supplements recently.I cannot do regular physical activities due to musculoskeletal issues.I haven't had active cancer in the last 3 years, except for certain types.I use certain medications or substances.I am currently very sick with or without a fever.I have had certain abdominal surgeries or severe gut issues.I regularly use prescription pain medication that contains opiates.I am between 18 and 60 years old.My liver tests are more than three times the normal limit.I have been hospitalized for a mental health condition or changed my depression or anxiety medication in the last 10 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Short-term, Western Diet, high MedDiet score a Intervention: C
- Group 2: Short-term, Western Diet, high MedDiet score a Intervention: W
- Group 3: Long-term a Intervention: CLEAN-MED
- Group 4: Short-term, Western Diet, low MedDiet score a Intervention: We
- Group 5: Short-term, Western Diet, low MedDiet score a Intervention: CL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is the research team recruiting participants for this clinical investigation?
"Yes, the data held by clinicaltrials.gov confirms that recruitment for this medical trial is ongoing. It was first announced on August 26th 2022 and had its most recent update on November 2nd 2022. Around 1000 people are required to take part in this experiment at a single site."
Answered by AI
Might I be eligible to partake in this clinical experiment?
"This medical experiment is searching for 1000 volunteers aged 18 to 60 with existing dietary habits. The ideal participant additionally needs to meet the following requirements: age of consent, any gender/ethnicity, able and willing to provide bodily specimens (blood & stool), body mass index between 18-35 kg/m^2, access to contemporary technological tools (computers, smartphones etc.) plus transportation resources in order to attend necessary visits on site; depending on the cohort they belong to - either short or long term - they must have a PREDIMED-17 MedDiet score no higher than 7 and CLEAN-MED NOVA score of"
Answered by AI
Do participants of advanced age qualify for this research study?
"This medical study is seeking participants that are of legal age or older, yet younger than sixty years old."
Answered by AI
Are there any available slots for potential participants in this research project?
"The trial is currently open to applicants according to information published on clinicaltrials.gov. The medical study was first posted on August 26th 2022 and last updated on November 2nd 2022."
Answered by AI
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