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NCT03623308 · ClinicalTrials.gov registry record · NA
Whole Grain and Fiber Addition Study
A NA study, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT03623308: Completed NA study, sponsored by University of Minnesota.
NCT03623308 is a NA study that has completed, run by University of Minnesota. The registered enrollment target is 29 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
NCT03623308, a NA study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study Summary
The human gut microbiota is the complex community of bacteria that reside within the human gastrointestinal tract. This community plays an important role in supporting normal immune function and digestion. Disruption of the microbial communities within the gastrointestinal tract, sometimes termed "dysbiosis" is linked to a wide range of human diseases, including obesity, metabolic syndrome, malnutrition, and cancer. Stability of the microbiome is thought to be important for human health, however the factors that drive microbiome community stability are poorly understood. Within the gastrointestinal tract, the microbiota is constantly exposed to complex mixtures of foods and the products of digestion. Importantly, changes in diet have been shown to rapidly induce shifts in microbial community composition. These compositional shifts can also affect microbial production of bioactive metabolites, which may be one mechanism to explain how the microbiome impacts host physiology and disease. Fiber is often considered to be one of the largest contributors to microbial compositional shifts that follow dietary interventions. Fiber resists digestion and persists through the gastrointestinal tract to reach the large intestine where it can be metabolized by bacteria. The end products of this metabolism are the short chain fatty acids (SCFAs), acetate and butyrate, which are often associated with beneficial health outcomes. Fibrous foods are also a source of polyphenols and other phenolic compounds that may be used by microbes in the production of secondary metabolites or freed from the food matrix by microbial enzymes. The purpose of this study is to: 1) to investigate the impact of high fiber, whole grain and bran cereal on microbiome stability, and 2) to explore the microbial contribution to polyphenol metabolism from whole grain in healthy individuals.
Primary Outcome
Shotgun metagenomic sequencing of stool samples
Interventions
- OTHER Fiber cereal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-05-04 |
| Est. Completion | 2019-03-01 |
| Phase | NA |
What the finished NCT03623308 record still lists
NCT03623308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 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 1 intervention - of which Fiber cereal is the first listed.
NCT03623308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03623308 about?
NCT03623308 is a clinical study titled "Whole Grain and Fiber Addition Study". The human gut microbiota is the complex community of bacteria that reside within the human gastrointestinal tract. This community plays an important role in supporting normal immune function and digestion. Disruption of the microbial communities within the gastrointestinal tract, sometimes termed "d...
What is the current status of trial NCT03623308?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2018-05-04. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT03623308?
The interventions under investigation include: Fiber cereal (OTHER).
Who is sponsoring clinical trial NCT03623308?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03623308's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 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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