---
title: Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing
nct_id: NCT03539666
overall_status: COMPLETED
phase: NA
sponsor: South Dakota State University
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03539666.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03539666"
ct_last_update_post_date: 2021-11-10
last_seen_at: "2026-05-12T06:22:16.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing

**Official Title:** The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing

**NCT ID:** [NCT03539666](https://clinicaltrials.gov/study/NCT03539666)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 38
- **Lead Sponsor:** South Dakota State University
- **Conditions:** Healthy
- **Start Date:** 2018-07-27
- **Completion Date:** 2019-04-16
- **CT.gov Last Update:** 2021-11-10

## Brief Summary

The project will characterize human gut microbiome response to two different diets and the possible physiological and biochemical implications of such response on cardiometabolic risk factors. The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

## Detailed Description

The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* generally good health status based on one routine physical in the past 15 months, current health status
* normal HbA1C, weigh 110 lb or more
* Age 50 years or more, generally healthy, all races and both sexes
* generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
* willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
* impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* major gastrointestinal disorders in the past 3 months
* history of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they had not had a routine health checkup during the 12 months prior to recruitment.
* If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.
```

## Arms

- **Pork** (EXPERIMENTAL) — Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans.
- **Poultry** (EXPERIMENTAL) — Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans.

## Interventions

- **diet** (OTHER) — dietary patterns

## Primary Outcomes

- **Microbiota-dependent TMAO-response, measured as serum concentration** _(time frame: 10 days per diet arm)_ — targeted sequencing
- **Serum concentration of biogenic amine metabolites** _(time frame: 10 days per diet arm)_ — Metabolomics

## Locations (1)

- South Dakota State University, Wagner Hall 416, Brookings, South Dakota, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.south dakota state university, wagner hall 416|brookings|south dakota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03539666.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03539666*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*