SCF Supplementation for Bone Health in Adolescents
(MetA-Bone Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial excludes participants who have a chronic illness requiring regular medication use, so if you are on regular medications for a chronic condition, you would not be eligible to participate.
What data supports the effectiveness of the treatment Soluble Corn Fiber (SCF) for bone health in adolescents?
Is soluble corn fiber (SCF) safe for human consumption?
How does the treatment with Soluble Corn Fiber (SCF) and Calcium differ from other treatments for bone health in adolescents?
The treatment with Soluble Corn Fiber (SCF) and Calcium is unique because SCF is a prebiotic fiber that can enhance calcium absorption in adolescents, potentially improving bone health. Unlike traditional calcium supplements, SCF works by interacting with gut bacteria to increase calcium absorption, which may be beneficial for those with low dietary calcium intake.12678
What is the purpose of this trial?
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.
Research Team
Cristina Palacios, PhD
Principal Investigator
Department of Dietetics, College of Public Health, Florida International Univ.
Eligibility Criteria
This trial is for healthy adolescents aged 10-13 who fall within the 5th to 85th percentiles for body mass index according to CDC growth charts. It's not open to those regularly taking calcium supplements over 500 mg/day, vitamin D over 400 IU/day, or anyone with a chronic illness requiring regular medication.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive soluble corn fiber (SCF) supplementation for 1 year to assess its effects on bone metabolism
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Placebo + calcium
- Soluble Corn Fiber (SCF) + Calcium
- Soluble Corn Fiber (SCF) without Calcium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida International University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator