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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
Must not have
Symptomatic gallstones
Consumption of specific drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks (short term) 12 months (long term)
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have painful gallstones.
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I am currently taking certain medications.
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I have not had heart disease or conditions in the last year.
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My kidney function is low (eGFR under 50).
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I have not used weight or appetite control supplements, including laxatives, in the last 4 weeks.
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I am not fluent in English.
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I weigh less than 100 lbs.
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I cannot do regular physical activities due to musculoskeletal issues.
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I haven't had active cancer in the last 3 years, except for certain types.
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I am currently very sick with or without a fever.
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I have had certain abdominal surgeries or severe gut issues.
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I regularly use prescription pain medication that contains opiates.
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My liver tests are more than three times the normal limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks (short term) 12 months (long term)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks (short term) 12 months (long term) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Identify associations between Mediterranean-like unprocessed food diet adherence with perceived quality of life.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
389 Previous Clinical Trials
30,878,736 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

CLEAN-MED Diet (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05411120 — N/A
Diet Therapy Research Study Groups: Short-term, Western Diet, high MedDiet score a Intervention: C, Short-term, Western Diet, high MedDiet score a Intervention: W, Long-term a Intervention: CLEAN-MED, Short-term, Western Diet, low MedDiet score a Intervention: We, Short-term, Western Diet, low MedDiet score a Intervention: CL
Diet Therapy Clinical Trial 2023: CLEAN-MED Diet Highlights & Side Effects. Trial Name: NCT05411120 — N/A
CLEAN-MED Diet (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05411120 — N/A
~491 spots leftby Apr 2027
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