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NCT04611217 · ClinicalTrials.gov registry record · NA
Dietary Fiber Effects on the Microbiome and Satiety
A NA study of Dietary Fiber, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- NA
- Development phase
- 88
- Enrollment target
- 1
- Study location
NCT04611217 is a NA study of Dietary Fiber that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 88 participants, above the 47-participant average among 3 other Dietary Fiber trials with a reported enrollment target (87% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04611217, a NA study of Dietary Fiber, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
- 1
- Study location
Study Summary
Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These stu
Conditions Studied
Interventions
- OTHER Dietary fiber: 10-25g
- OTHER Dietary fiber: 5g
Study Locations (1)
Missouri
- University of Missouri-Columbia - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04611217
The ClinicalTrials.gov registry entry for NCT04611217 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 47-participant average among 3 other Dietary Fiber trials with a reported enrollment target (87% higher). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dietary Fiber appearing as the primary indexed condition, and to 2 interventions - of which Dietary fiber: 10-25g is the first listed.
NCT04611217 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04611217 about?
NCT04611217 is a clinical study titled "Dietary Fiber Effects on the Microbiome and Satiety". Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/da...
What is the current status of trial NCT04611217?
This trial is currently recruiting. It is a NA study. The enrollment target is 88 participants. The study started on 2021-04-22. Estimated completion is 2025-08-01.
What conditions does trial NCT04611217 study?
This clinical trial studies the following conditions: Dietary Fiber.
What interventions are being tested in trial NCT04611217?
The interventions under investigation include: Dietary fiber: 10-25g (OTHER), Dietary fiber: 5g (OTHER).
Who is sponsoring clinical trial NCT04611217?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04611217 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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