HealthyNCT03539666
Effect of Diets on the Gut Microbiota Composition and Cardiometabolic Wellbeing
A study testing diet in people with Healthy, run by South Dakota State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2018to 16 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University, Wagner Hall 416
Brookings, South Dakota, 57007
About this study
Official title: The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing
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.
Read the detailed description
The study will use controlled-feeding, systems-biology, metagenomic, and metabolomic approaches to examine American dietary patterns.
- Conditions
- Healthy
- Being tested
- diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
Also called poultry
dietary patterns
| Study group | Role | What they receive |
|---|---|---|
| Pork | Experimental | Standard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans. Receives: Other: diet |
| Poultry | Experimental | Standard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans. Receives: Other: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota-dependent TMAO-response, measured as serum concentration
targeted sequencing
Measured: 10 days per diet arm
Serum concentration of biogenic amine metabolites
Metabolomics
Measured: 10 days per diet arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start27 Jul 2018
- Primary completion14 Mar 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moul Dey, South Dakota State University
- Investigators
- Moul Dey, Ph.D, Principal investigator, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539666
- Sponsor's protocol ID
- IRB-1804010-EXP
- Status last verified
- Oct 2021
- First submitted
- 16 May 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhakal S, Moazzami Z, Perry C, Dey M. Effects of Lean Pork on Microbiota and Microbial-Metabolite Trimethylamine-N-Oxide: A Randomized Controlled Non-Inferiority Feeding Trial Based on the Dietary Guidelines for Americans. Mol Nutr Food Res. 2022 May;66(9):e2101136. doi: 10.1002/mnfr.202101136. Epub 2022 Mar 3.
PubMed 35182101
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pork and Chicken Diets on Gut Microbiota Composition and Metabolites Related to Cardiometabolic Wellbeing
- ClinicalTrials.gov ID
- NCT03539666
- Acronym / sponsor ID
- IRB-1804010-EXP
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pork | Experimental | Other: dietStandard American Diet with meat source: lean pork. Diet adheres to 2015-2020 Guidelines for Americans. |
| Poultry | Experimental | Other: dietStandard American Diet with meat source: chicken. Diet adheres to 2015-2020 Guidelines for Americans. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietAlso: poultrydietary patterns | Other | Pork, Poultry |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 35182101Dhakal S, Moazzami Z, Perry C, Dey M. Effects of Lean Pork on Microbiota and Microbial-Metabolite Trimethylamine-N-Oxide: A Randomized Controlled Non-Inferiority Feeding Trial Based on the Dietary Guidelines for Americans. Mol Nutr Food Res. 2022 May;66(9):e2101136. doi: 10.1002/mnfr.202101136. Epub 2022 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moul Dey, Ph.D principal investigator
South Dakota State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet in people with Healthy, run by South Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota-dependent TMAO-response, measured as serum concentration (time frame: 10 days per diet arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.