# Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices

> **NIH NIH R33** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $111,158

## Abstract

PROJECT SUMMARY
The obesity epidemic has fueled major increases in cardiometabolic diseases. A growing body of evidence
suggests that cardiometabolic diseases are associated with an altered gut microbiota. Observational and
intervention data agree that there is suggestive evidence that a heart-healthy Mediterranean-style diet may be
associated with beneficial changes in gut microbiota. However, the literature has yet to reach consensus. More
research needs to be done on how the gut microbiota may mediate dietary effects on cardiometabolic risk
within community-based dietary interventions. It is important that scholarship take place within community-
based dietary interventions so that the dietary changes being measured are of whole diets (rather than a
specific dietary component) and thus are more sustainable by participants. To address these gaps, this grant
proposes a diversity supplement to the Randomized Explanatory Trial of a Mediterranean Dietary Pattern
Weight Loss Intervention for Primary Care Practices (R33HL142680). The overarching purpose of the parent
R33 is to test whether a weight loss intervention emphasizing a healthful eating pattern (Med-South) can yield
long-term weight loss and improved CVD risk profiles over usual care (WWTM—formerly Weight Watchers).
The study will test the impact of the Med-South intervention by assessing outcomes at 4, 12, and 24 months in
a sample of 360 patients. Fecal samples will also be collected at each timepoint. The current proposal
leverages the patients recruited in the parent R33 to investigate the impacts of the Med-South intervention on
the gut microbiota over time. To do this, we will complete 16S rRNA sequencing on stool DNA using baseline
and 4-month intervention samples. Our goals are to (1) assess cross-sectional association between
participants' baseline pre-intervention diet and microbiota composition, and (2) test the changes in the gut
microbial community composition from baseline through four months of intervention follow-up. For each study
participant, microbial measures for analysis include: (1) alpha-diversity, (2) beta-diversity, and (3) abundances
of distinct taxa (genera).

## Key facts

- **NIH application ID:** 10631776
- **Project number:** 3R33HL142680-04S2
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** THOMAS C KEYSERLING
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $111,158
- **Award type:** 3
- **Project period:** 2019-06-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10631776

## Citation

> US National Institutes of Health, RePORTER application 10631776, Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices (3R33HL142680-04S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10631776. Licensed CC0.

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