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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT02916862

Run by

Florida International University

People needed

177

Starts

2020-02-10

Expected to finish

2025-04-30

Last updated by the study team

2025-11-10

Who can join

Age: 9 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.

You may not qualify if…

• 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

Where it is running

• Flroida International University — Miami, Florida, United States

Full record on ClinicalTrials.gov

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