Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
MetA-Bone
2 other identifiers
interventional
177
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedResults Posted
Study results publicly available
October 29, 2025
CompletedNovember 10, 2025
October 1, 2025
5.2 years
August 25, 2016
September 26, 2025
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Whole Body Bone Mineral Content (BMC)
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
12 months
Secondary Outcomes (1)
Change in Spine BMC
12 months
Study Arms (4)
Soluble Corn Fiber (SCF) + Calcium
EXPERIMENTALThis group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Soluble Corn Fiber (SCF) without calcium
ACTIVE COMPARATORThis group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Placebo
PLACEBO COMPARATORThis group will receive a similar supplement without SCF or calcium, administered twice a day
Placebo + calcium
PLACEBO COMPARATORThis group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day
Interventions
Participants will consume a supplement with 12 g/day of SCF for 12 months
Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
Participants will consume a supplement without SCF or calcium carbonate for 12 months
Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Flroida International University
Miami, Florida, 33199, United States
Related Publications (1)
Palacios C, Leone J, Clayton P, Hernandez J, Trak-Fellermeier MA, Macchi A, Ramirez-Roggio D, Cobo Y, Bautista S, Connelly J, Elington M, Romero J, Galvan R. Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children. Contemp Clin Trials. 2024 Dec;147:107715. doi: 10.1016/j.cct.2024.107715. Epub 2024 Oct 15.
PMID: 39413989DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cristina Palacios
- Organization
- Florida International University
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina Palacios, PhD
Department of Dietetics, College of Public Health, Florida International Univ.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair
Study Record Dates
First Submitted
August 25, 2016
First Posted
September 28, 2016
Study Start
February 10, 2020
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
November 10, 2025
Results First Posted
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- When the primary outcome is completed.
- Access Criteria
- We will share the data and associated documentation only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Investigators outside the research team will only be granted access to the data after their proposal has been evaluated and approved by the research team and by the Florida International University Office of Research Integrity. We will only provide access to the samples and de-identified data as required to address the proposed research goals and only under a data-sharing agreement.