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NCT02433873 · ClinicalTrials.gov registry record · NA
Prebiotic Effects of Isomalto-oligosaccharide
A NA study of Microbiota, sponsored by George Mason University.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT02433873 is a NA study of Microbiota that has completed, run by George Mason University. The registered enrollment target is 54 participants, below the 134-participant average among 10 other Microbiota trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02433873, a NA study of Microbiota, has completed, sponsored by George Mason University.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement on gut microbiome, gut health, and body weight. Two formulations of the supplement will be evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo. Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, body weight, and gut health data will be compared across supplement and placebo groups. Primary Aim 1: To evaluate the effect of the IMO supplement on gut bacterial abundance, diversity, and gene function across intervention and placebo groups, and across two doses of the intervention. Secondary Aim 1: To evaluate the effect of the IMO supplement on gut health across intervention and placebo groups, and across two doses of the intervention. Secondary Aim 2: To evaluate the effect of the IMO supplement on body weight across intervention and placebo groups, and across two doses of the intervention. 60 subjects, randomized to three arms (20 each: Supplement formula A, Supplement formula B or placebo) will take a daily dose of Supplement A, Supplement B, or placebo for 8 weeks. The supplement is a light syrup liquid. Ingredients that are in the supplement are: isomalto-oligosaccharide, water, mannitol, maltose, glucose, and glycerol. Ingredients that are in the placebo are: high maltose corn syrup (Satin Sweet™), water, and mannitol. Dose will be 500 mg during the first 4 weeks and then 1000 mg for second 4 weeks. Subjects will be instructed to take 500 mg/day of the supplement or placebo the first four weeks and 1000 mg/day of the supplement or placebo for the second four weeks. Subjects will be blinded as to whether they are receiving placebo or supplement. After screening and once enrolled, subject involvement includes visits to George Mason University, being weighed, dropping off stool samples, and completing a survey on gut health. Stool samples will be analyzed for bacterial DNA. The gut bacterial DNA, weight, and gut h
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Isomalto-oligosaccharide
Study Locations (1)
Virginia
- George Mason University - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02433873
The ClinicalTrials.gov registry entry for NCT02433873 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 134-participant average among 10 other Microbiota trials with a reported enrollment target (60% lower). The listed sponsor is George Mason University, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Microbiota appearing as the primary indexed condition, and to 1 intervention - of which Isomalto-oligosaccharide is the first listed.
NCT02433873 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT02433873 about?
NCT02433873 is a clinical study titled "Prebiotic Effects of Isomalto-oligosaccharide". The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement on gut microbiome, gut health, and body weight. Two formulations of the supplement will be evaluated; thus, there will be three study arms: Supplement A, Supplement B, and placebo. Stool samples will be anal...
What is the current status of trial NCT02433873?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2015-04. Estimated completion is 2016-12.
What conditions does trial NCT02433873 study?
This clinical trial studies the following conditions: Microbiota.
What interventions are being tested in trial NCT02433873?
The interventions under investigation include: Isomalto-oligosaccharide (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02433873?
This trial is sponsored by George Mason University, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02433873 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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