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NCT04729816 · ClinicalTrials.gov registry record · NA
Assessing the Dose Response of a Lead Fiber Snack Prototype
A NA study of Microbiota and Gastrointestinal Microbiome, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04729816 is a NA study of Microbiota and Gastrointestinal Microbiome that has completed, run by Washington University School of Medicine. The registered enrollment target is 17 participants, below the 138-participant average among 10 other Microbiota trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04729816, a NA study of Microbiota and Gastrointestinal Microbiome, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes. Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (\~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.
Conditions Studied
Interventions
- OTHER Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2021-11-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04729816
The ClinicalTrials.gov registry entry for NCT04729816 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 10 other Microbiota trials with a reported enrollment target (88% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Microbiota appearing as the primary indexed condition, and to 1 intervention - of which Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food. is the first listed.
NCT04729816 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04729816 about?
NCT04729816 is a clinical study titled "Assessing the Dose Response of a Lead Fiber Snack Prototype". Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled ...
What is the current status of trial NCT04729816?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2021-02-22. Estimated completion is 2021-11-15.
What conditions does trial NCT04729816 study?
This clinical trial studies the following conditions: Microbiota, Gastrointestinal Microbiome.
What interventions are being tested in trial NCT04729816?
The interventions under investigation include: Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food. (OTHER).
Who is sponsoring clinical trial NCT04729816?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04729816 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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