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

NCT02916862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2025-11-10

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Soluble Corn Fiber (SCF) without Calcium

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

COMBINATION_PRODUCT

Soluble Corn Fiber (SCF) + Calcium

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

DIETARY_SUPPLEMENT

Placebo

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

COMBINATION_PRODUCT

Placebo + calcium

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Florida International University

    lead OTHER

Principal Investigators

  • Cristina Palacios, PhD · Department of Dietetics, College of Public Health, Florida International Univ.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916862 on ClinicalTrials.gov