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

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.