Phase 2
Completed N=177
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Source: ClinicalTrials.gov NCT02916862 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Change in Whole Body Bone Mineral Content (BMC) — 20.1; 18.6; 17.3; 20.7 grams — p=0.377
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Whole Body Bone Mineral Content (BMC) |
20.1; 18.6; 17.3; 20.7 | 0.377 |
| SECONDARY Change in Spine BMC |
21.8; 18.7; 22.4; 23.8 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.
Exclusion Criteria
- Subjects with any chronic illness requiring regular medication use.
- Those taking calcium supplements (>500 mg/d) and vitamin D supplements (>400 IU/d) on a regular basis
Data sourced from ClinicalTrials.gov (NCT02916862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.