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NCT01288508 · ClinicalTrials.gov registry record · NA
Investigation of Supra Fiber in the Treatment of Adults With Constipation
A NA study, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 89
- Enrollment target
NCT01288508 is a NA study that has completed, run by Augusta University. The registered enrollment target is 89 participants.
The verdict
NCT01288508, a NA study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 89 participants
- Enrollment target
Study Summary
Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention, hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy but also the palatability and tolerability of Supra Fiber in the treatment of chronic constipation. Aims: 1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5 grams BID) on the number of complete spontaneous bowel movements per week, and bowel symptoms. 2. To examine the effects of fiber supplements on taste and quality of life in adults with functional chronic constipation in a randomized, double-blind, parallel group controlled trial. Methods: We propose to enroll 90 subjects with functional constipation in a single blinded, randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with Psyllium Data analysis: The primary outcome measure will be the global relief of constipation symptoms as rated by the subject at the end of each phase of the study. Additionally, we will assess several secondary outcome measures that will include the number of Complete Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient rating of constipation-related symptoms. Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of constipation compared to the baseline. This improvement will be comparable or superior to that ac
Interventions
- DIETARY_SUPPLEMENT Psyllium
- DIETARY_SUPPLEMENT Supra Fiber
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288508
The ClinicalTrials.gov registry entry for NCT01288508 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psyllium is the first listed.
NCT01288508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288508 about?
NCT01288508 is a clinical study titled "Investigation of Supra Fiber in the Treatment of Adults With Constipation". Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and Acai berries. Unlike psy...
What is the current status of trial NCT01288508?
This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2010-10. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01288508?
The interventions under investigation include: Psyllium (DIETARY_SUPPLEMENT), Supra Fiber (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01288508?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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