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NCT02916862 · ClinicalTrials.gov registry record · Phase 2
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
A Phase 2 study, sponsored by Florida International University.
- Completed
- Registry status
- Phase 2
- Development phase
- 177
- Enrollment target
NCT02916862 is a Phase 2 study that has completed, run by Florida International University. The registered enrollment target is 177 participants.
The verdict
NCT02916862, a Phase 2 study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 177 participants
- Enrollment target
Study Summary
The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF) supplementation for 1 year on bone metabolism in growing adolescents compared to controls. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy adolescents aged 10-13 years, equally randomly assigned to one of four intervention groups: SCF (12 g/d), SCF + calcium (12 g/d of SCF + 600 mg/d of elemental calcium), placebo (0 g/d of SCF or of calcium), and placebo + calcium (0 g/d of SCF + 600 mg/d of elemental calcium); all administered twice a day. Bone mass will be assessed at baseline at 6 months and at 12 months and bone related biomarkers and fecal microbiome will be assessed at baseline and at 12 months.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Soluble Corn Fiber (SCF) without Calcium
- COMBINATION_PRODUCT Soluble Corn Fiber (SCF) + Calcium
- COMBINATION_PRODUCT Placebo + calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02916862
The ClinicalTrials.gov registry entry for NCT02916862 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02916862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02916862 about?
NCT02916862 is a clinical study titled "Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents". The primary aim of this proposal is to determine the effects of soluble corn fiber (SCF) supplementation for 1 year on bone metabolism in growing adolescents compared to controls. For the proposed study, a randomized double-blinded placebo controlled clinical trial will be conducted in 236 healthy a...
What is the current status of trial NCT02916862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 177 participants. The study started on 2020-02-10. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT02916862?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Soluble Corn Fiber (SCF) without Calcium (DIETARY_SUPPLEMENT), Soluble Corn Fiber (SCF) + Calcium (COMBINATION_PRODUCT), Placebo + calcium (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT02916862?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
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