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Prebiotic Effects of Isomalto-oligosaccharide
NCT02433873 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Mason University, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02433873 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02433873?
The interventions under investigation include: Isomalto-oligosaccharide (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02433873?
This trial is sponsored by George Mason University, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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