Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults

Diet Therapy Clinical Trial

Official title: Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Study Description:

This study (called the CLEAN-MED Diet Study) seeks to examine associations between the gut microbiome, well-being, and adherence to a Mediterranean-like unprocessed food diet. The premise of this study is based on the well-known health benefits of a healthy Mediterranean diet and the potential role that the gut microbiota may serve as a factor in health and disease. The study will recruit healthy outpatient adults, who agree to adhere to a strict Mediterranean-like diet with unprocessed foods, meticulously log their food intake and perceived quality of life using provided questionnaires/tools, and who agree to collect periodic biological samples for analysis. The study will consist of: (1) a short-term cohort who will complete a crossover study design with their habitual Western diet for 4 weeks and the intervention Mediterranean-like unprocessed food diet for 4 weeks (with CLEAN-MED diet food provided by the NIH metabolic kitchen), and (2) a long-term cohort who will continuously adhere to the Mediterranean-like unprocessed food diet for 12 months, following assessment of their baseline diet (with some CLEAN-MED diet foods provided for up to the first 2 weeks of the long-term study, after which the participants must provide their own food).

Objectives:

Primary Objective:

-The primary objective is to measure changes within the gut microbiome in healthy adults who adhere to a Mediterranean-like unprocessed food diet plan.

Secondary Objectives:

• Identify associations between Mediterranean-like unprocessed food diet adherence and psychosocial variables, such as perceived quality of life.

• Identify associations between changes in the gut microbiome and additional biomarkers.

Tertiary Objective:

-Measure the level of adherence to the diet given a strict request for data submission.

Endpoints:

Primary Endpoint:

-Measure changes in gut microbiota composition and functionality from periodic stool sampling using either 16S rRNA and/or shotgun sequencing.

Secondary Endpoints:

• Identify associations between Mediterranean-like unprocessed food diet adherence with perceived quality of life using surveys/questionnaires.

• Measure biomarkers in various biological specimens (stool, blood, and urine) using the pertinent biochemical assays. ;

Related Conditions & MeSH terms

• Diet Therapy

• NCT number: NCT05411120
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Crystal K Awuah
• Phone: (301) 594-9490
• Email: crystal.awuah@nih.gov
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2022
• Completion date: April 1, 2027