CLEAN-MED Diet for Healthy Gut Microbiome
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you do not use certain medications, such as those for weight control, diabetes, cholesterol, and some others. If you are taking any of these, you may need to stop before joining the study.
What data supports the effectiveness of the CLEAN-MED Diet treatment for a healthy gut microbiome?
Research shows that the Mediterranean diet, which is similar to the CLEAN-MED Diet, can positively change the gut microbiome by increasing beneficial bacteria and reducing inflammation. This diet is linked to lower risks of diseases like heart disease and some cancers, suggesting it may help maintain a healthy gut.12345
Is the CLEAN-MED Diet safe for humans?
How does the CLEAN-MED Diet treatment differ from other treatments for a healthy gut microbiome?
The CLEAN-MED Diet, a Mediterranean-like Unprocessed Diet, is unique because it focuses on modulating the gut microbiome through a diet rich in plant-based foods, healthy fats, and low in processed foods, which can lead to beneficial changes in gut bacteria and reduce inflammation. Unlike other treatments, it emphasizes a holistic lifestyle approach, including dietary counseling and physical activity, to improve gut health.12567
Research Team
Karen M Frank, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Trial Week
Participants log all food intake and answer dietary questions
Short-term Treatment
Participants in the short-term group consume a Western diet for 4 weeks followed by a CLEAN-MED diet for 4 weeks
Long-term Treatment
Participants in the long-term group consume a CLEAN-MED diet for up to 12 months
Follow-up
Participants are monitored for changes in gut microbiome and quality of life
Treatment Details
Interventions
- CLEAN-MED Diet
- Western Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institutes of Health Clinical Center (CC)
Lead Sponsor