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NCT03924778 · ClinicalTrials.gov registry record · NA
Modifying Diet to Improve Gut Microbiome
A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Not yet
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03924778: Clinical Trial NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03924778 is a NA study that has not yet begun recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03924778, a NA study, has not yet begun recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.
Primary Outcome
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Interventions
- BEHAVIORAL DASH diet
- BEHAVIORAL standard American diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-07 |
| Est. Completion | 2026-08 |
| Phase | NA |
What is known before NCT03924778 opens enrollment
NCT03924778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which DASH diet is the first listed.
NCT03924778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03924778 about?
NCT03924778 is a clinical study titled "Modifying Diet to Improve Gut Microbiome". The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study fo...
What is the current status of trial NCT03924778?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 28 participants. The study started on 2026-07. Estimated completion is 2026-08.
What interventions are being tested in trial NCT03924778?
The interventions under investigation include: DASH diet (BEHAVIORAL), standard American diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT03924778?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03924778's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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