Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02916862
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 177 participants
Conditions and interventions
Conditions
Interventions
- Soluble Corn Fiber (SCF) without Calcium Dietary Supplement
- Soluble Corn Fiber (SCF) + Calcium Combination Product
- Placebo Dietary Supplement
- Placebo + calcium Combination Product
Dietary Supplement · Combination Product
Eligibility (public fields only)
- Age range
- 9 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 10, 2020 (Actual)
- Primary completion
- Apr 30, 2025 (Actual)
- Completion
- Apr 30, 2025 (Actual)
- Last update posted
- Nov 10, 2025
2020 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Flroida International University | Miami | Florida | 33199 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02916862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2025 · Synced Nov 15, 2026
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