MedDataX Logo

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

NCT ID: NCT02916862

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The adolescent period is crucial for optimizing future bone health because bone accumulates rapidly during these years and accounts for up to half of adult peak bone mass. Calcium intake during this period is critical for adequate bone mineralization but this is the nutrient most deficient in the diets of adolescents. A strategy to maximize bone mineralization during this critical period is to increase the absorption of the calcium being consumed. This could be achieved by supplementing diets with certain non-digestible carbohydrates, such as soluble corn fiber (SCF).

The primary aim of this study is to determine the effects of SCF supplementation for 1 year on bone metabolism in growing adolescents compared to controls. 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. The treatments will be provided in the form of flavored drinks twice per day (this was previously used in a short-term study among adolescents with excellent acceptance). Bone mass and anthropometric measurements 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. Assessment visits will be conducted in the Clinical Research Center of the Stempel School of Public Health at Florida International University. We will also have short home visits at 3 and 9 months to collect unused supplements and provide more supplements. In all visits, participants will complete several questionnaires, such as general health, diet and activity questionnaire. Compliance will be evaluated at all visits and also in real time using a study mobile app.

The primary outcome is change in bone mineral content (BMC) measured using Dual-energy X-ray absorptiometry (DXA)

The secondary outcomes include biochemical markers reflecting vitamin D status, calcium homeostasis and bone, such as serum calcium, phosphorus, creatinine, osteocalcin, carboxy-terminal collagen crosslinks (CTX), parathyroid hormone (PTH), bone specific alkaline phosphatase, 25-(OH) vitamin D3, 1,25-(OH)2 vitamin D3, and insulin growth factor 1 (IGF-I) and urinary calcium, phosphorus, creatinine and N-telopeptide cross-links.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fiber calcium absorption bone mass adolescents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

we are testing a fiber and calcium supplement so it is not a drug
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Soluble Corn Fiber (SCF) + Calcium

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

Group Type EXPERIMENTAL

Soluble Corn Fiber (SCF) + Calcium

Intervention Type COMBINATION_PRODUCT

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

Soluble Corn Fiber (SCF) without calcium

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

Group Type ACTIVE_COMPARATOR

Soluble Corn Fiber (SCF) without Calcium

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

This group will receive a similar supplement without SCF or calcium, administered twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo + calcium

This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day

Group Type PLACEBO_COMPARATOR

Placebo + calcium

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Soluble Corn Fiber (SCF) without Calcium

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

Intervention Type DIETARY_SUPPLEMENT

Soluble Corn Fiber (SCF) + Calcium

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

Intervention Type COMBINATION_PRODUCT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Placebo + calcium

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cristina Palacios, PhD

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristina Palacios, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dietetics, College of Public Health, Florida International Univ.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Flroida International University

Miami, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39413989 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01HD098589-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

107593

Identifier Type: -

Identifier Source: org_study_id