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NCT04538482 · ClinicalTrials.gov registry record · NA
DASH INtervention to INvestigate the Gut
A NA study of Cancer and Microbiota, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- NA
- Development phase
- 115
- Enrollment target
- 1
- Study location
NCT04538482 is a NA study of Cancer and Microbiota that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 115 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04538482, a NA study of Cancer and Microbiota, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
Conditions Studied
Interventions
- BEHAVIORAL DASH Diet
- BEHAVIORAL standard American diet
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04538482
The ClinicalTrials.gov registry entry for NCT04538482 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (97% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which DASH Diet is the first listed.
NCT04538482 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04538482 about?
NCT04538482 is a clinical study titled "DASH INtervention to INvestigate the Gut". The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided b...
What is the current status of trial NCT04538482?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 115 participants. The study started on 2022-03-07. Estimated completion is 2026-05-31.
What conditions does trial NCT04538482 study?
This clinical trial studies the following conditions: Cancer, Microbiota.
What interventions are being tested in trial NCT04538482?
The interventions under investigation include: DASH Diet (BEHAVIORAL), standard American diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT04538482?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04538482 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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