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NCT05411120 · ClinicalTrials.gov registry record · NA
Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
NCT05411120 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 160 participants.
The verdict
NCT05411120, a NA study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
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.
Interventions
- OTHER Western Diet
- OTHER CLEAN-MED
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-08-26 |
| Est. Completion | 2026-02-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05411120
The ClinicalTrials.gov registry entry for NCT05411120 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Western Diet is the first listed.
NCT05411120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05411120 about?
NCT05411120 is a clinical study titled "Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults". 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 inc...
What is the current status of trial NCT05411120?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2022-08-26. Estimated completion is 2026-02-05.
What interventions are being tested in trial NCT05411120?
The interventions under investigation include: Western Diet (OTHER), CLEAN-MED (OTHER).
Who is sponsoring clinical trial NCT05411120?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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