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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: Completed Phase 2 study, sponsored by Florida International University.

NCT02916862 is a Phase 2 study that has completed, run by Florida International University. The registered enrollment target is 177 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)

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

FieldValue
Enrollment Target 177 participants
Start Date 2020-02-10
Est. Completion 2025-04-30
Phase Phase 2
Florida International University

89 total trials

What the finished NCT02916862 record still lists

NCT02916862 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT02916862 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02916862's enrollment target sits among peer trials

177 394th of 2000 higher than 1,607 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02916862, the US trial registry maintained by the National Library of Medicine. NCT02916862 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.