CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 177 enrolled
Drug / intervention
Soluble Corn Fiber (SCF) + Calcium +3 morecombination
Likely dose
Soluble Corn Fiber (SCF) + Calcium 12 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02916862
NCT02916862Phase 2Completed
CompareCT.gov

Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents

Florida International University·interventional·Posted Sep 28, 2016·Updated Nov 10, 2025

In Brief

A Phase 2 clinical trial evaluating Soluble Corn Fiber (SCF) without Calcium, Soluble Corn Fiber (SCF) + Calcium, and 2 other interventions for Osteoporosis. Completed, enrolled 177 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 28, 2016
Enrollment StartFeb 10, 2020
Primary CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.8 years ago

Interventions

Soluble Corn Fiber (SCF) without Calciumdietary

Participants will consume a supplement with 12 g/day of SCF for 12 months

Soluble Corn Fiber (SCF) + Calciumcombination

Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months

Placebodietary

Participants will consume a supplement without SCF or calcium carbonate for 12 months

Placebo + calciumcombination

Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months