Eligibility
18 - 65
All Sexes
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Study Summary
Background: Trillions of tiny organisms-including bacteria, fungi, and viruses-live inside our intestines. These microorganisms break down nutrients in our food, aid our immunity, and help keep us healthy. The population balances among these organisms can vary in different people due to factors including genetics, lifestyle, and diet. More studies are needed to understand how dietary habits affect our intestinal microorganisms. Objective: To see how switching from a traditional Western diet (low in fiber, high in saturated fat) to a Mediterranean-like unprocessed foods diet (CLEAN-MED) changes the environment in the intestine. The CLEAN-MED diet includes lots of vegetables, fruits, and whole grains with little sugar or red meat. Eligibility: Healthy adults aged 18 to 60 Design: Participants will be divided into 2 groups. All will start with a trial week. Participants will log all the food they eat and answer questions about their diet throughout the entire study. Participants in the short-term group will eat a Western diet for 4 weeks and a CLEAN-MED diet for 4 weeks. Food will be provided for the CLEAN-MED diet. Participants will visit the clinic each week and complete surveys. They will log everything they eat. They will provide blood, urine, and stool samples. Participants in the long-term group will eat the CLEAN-MED diet for up to 12 months. They will visit the clinic each month and complete surveys. They will log everything they eat. They will provide blood, urine, and stool samples. Some foods will be provided for the first 2 weeks. Participants may choose to have a scan of their body composition every few months.
Treatment Effectiveness
Effectiveness Progress
Other trials for Diet Therapy
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 9 weeks (Short Term) 12 months (long Term)
24 months
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.
Month 12
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.
Trial Safety
Safety Progress
Other trials for Diet Therapy
Trial Design
5 Treatment Groups
Short-term, Western Diet, high MedDiet score a Intervention: W
1 of 5
Long-term a Intervention: CLEAN-MED
1 of 5
Short-term, Western Diet, low MedDiet score a Intervention: We
1 of 5
Short-term, Western Diet, high MedDiet score a Intervention: C
1 of 5
Short-term, Western Diet, low MedDiet score a Intervention: CL
1 of 5
Experimental Treatment
1000 Total Participants · 5 Treatment Groups
Primary Treatment: Short-term, Western Diet, high MedDiet score a Intervention: W · No Placebo Group · N/A
Short-term, Western Diet, high MedDiet score a Intervention: W
Other
Experimental Group · 1 Intervention: CLEAN-MED · Intervention Types: OtherLong-term a Intervention: CLEAN-MED
Other
Experimental Group · 1 Intervention: CLEAN-MED · Intervention Types: OtherShort-term, Western Diet, low MedDiet score a Intervention: We
Other
Experimental Group · 1 Intervention: CLEAN-MED · Intervention Types: OtherShort-term, Western Diet, high MedDiet score a Intervention: C
Other
Experimental Group · 1 Intervention: Western Diet · Intervention Types: OtherShort-term, Western Diet, low MedDiet score a Intervention: CL
Other
Experimental Group · 1 Intervention: Western Diet · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 weeks (short term) 12 months (long term)
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
2016First Recorded Clinical Trial
1 TrialsResearching Diet Therapy
270 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.
You are of any race, gender, or ethnicity.
You are willing to adhere to the dietary regimen and report any major stressors that occur during the study.
You have access to a computer, smartphone, or internet access.
You have the ability/transportation methods to attend on-site visits.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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