OsteoporosisPhase 2MetA-BoneNCT02916862
Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
A Phase 2 study testing Soluble Corn Fiber (SCF) without Calcium and Soluble Corn Fiber (SCF) + Calcium in people with Osteoporosis, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Soluble Corn Fiber (SCF) without Calcium and Soluble Corn Fiber (SCF) + Calcium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 30 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Flroida International University
Miami, Florida, 33199
About this study
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.
Read the detailed description
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
- Osteoporosis
- Being tested
- Soluble Corn Fiber (SCF) without Calcium, Soluble Corn Fiber (SCF) + Calcium, Placebo, Placebo + calcium
- Keywords
- fiber, calcium absorption, bone mass, adolescents
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble Corn Fiber (SCF) without CalciumDietary supplement
Participants will consume a supplement with 12 g/day of SCF for 12 months
Soluble Corn Fiber (SCF) + CalciumCombination product
Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
PlaceboDietary supplement
Participants will consume a supplement without SCF or calcium carbonate for 12 months
Placebo + calciumCombination product
Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Soluble Corn Fiber (SCF) + Calcium | Experimental | This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day Receives: Combination Product: Soluble Corn Fiber (SCF) + Calcium |
| Soluble Corn Fiber (SCF) without calcium | Active comparator | This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day Receives: Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium |
| Placebo | Placebo comparator | This group will receive a similar supplement without SCF or calcium, administered twice a day Receives: Dietary Supplement: Placebo |
| Placebo + calcium | Placebo comparator | This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day Receives: Combination Product: Placebo + calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (1)
Change in Spine BMC
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start10 Feb 2020
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- we are testing a fiber and calcium supplement so it is not a drug
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Cristina Palacios, PhD, Florida International University
- Investigators
- Cristina Palacios, PhD, Principal investigator, Department of Dietetics, College of Public Health, Florida International Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916862
- Sponsor's protocol ID
- 107593
- Other IDs
- 1R01HD098589-01
- Acronym
- MetA-Bone
- Status last verified
- Oct 2025
- First submitted
- 25 Aug 2016
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Palacios C, Trak-Fellermeier MA, Hernandez J, Galvan R, Martinez-Motta P, Machi A, Sifre-Acosta N, Clayton PK, Hernandez Y, Martinez R, Gambon T, Bursac Z, Weaver CM. Effect of soluble corn fiber supplementation for 1 year on bone mass in children and adolescents: results from the MetA-Bone randomized clinical trial. Am J Clin Nutr. 2026 Jun;123(6):101305. doi: 10.1016/j.ajcnut.2026.101305. Epub 2026 Apr 3.
PubMed 41936980Palacios 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.
PubMed 39413989
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
- ClinicalTrials.gov ID
- NCT02916862
- Acronym / sponsor ID
- MetA-Bone / 107593
- Conditions
- Osteoporosis
- Keywords
- fiber, calcium absorption, bone mass, adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- we are testing a fiber and calcium supplement so it is not a drug
| Arm | Type | Receives |
|---|---|---|
| Soluble Corn Fiber (SCF) + Calcium | Experimental | Combination Product: Soluble Corn Fiber (SCF) + CalciumThis 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 comparator | Dietary Supplement: Soluble Corn Fiber (SCF) without CalciumThis group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group will receive a similar supplement without SCF or calcium, administered twice a day |
| Placebo + calcium | Placebo comparator | Combination Product: Placebo + calciumThis group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble Corn Fiber (SCF) without CalciumParticipants will consume a supplement with 12 g/day of SCF for 12 months | Dietary supplement | Soluble Corn Fiber (SCF) without calcium |
| Soluble Corn Fiber (SCF) + CalciumParticipants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months | Combination product | Soluble Corn Fiber (SCF) + Calcium |
| PlaceboParticipants will consume a supplement without SCF or calcium carbonate for 12 months | Dietary supplement | Placebo |
| Placebo + calciumParticipants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months | Combination product | Placebo + calcium |
Primary outcome
Change in Whole Body Bone Mineral Content (BMC)
Time frame: 12 months
Participants underwent a bone scan at baseline and after 12-months in the intervention using a dual energy x-ray absorptiometry (DXA)
1 secondary outcome
Change in Spine BMC
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41936980Palacios C, Trak-Fellermeier MA, Hernandez J, Galvan R, Martinez-Motta P, Machi A, Sifre-Acosta N, Clayton PK, Hernandez Y, Martinez R, Gambon T, Bursac Z, Weaver CM. Effect of soluble corn fiber supplementation for 1 year on bone mass in children and adolescents: results from the MetA-Bone randomized clinical trial. Am J Clin Nutr. 2026 Jun;123(6):101305. doi: 10.1016/j.ajcnut.2026.101305. Epub 2026 Apr 3.
- Derived from this study: PubMed 39413989Palacios 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Palacios, PhD principal investigator
Department of Dietetics, College of Public Health, Florida International Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soluble Corn Fiber (SCF) without Calcium and Soluble Corn Fiber (SCF) + Calcium in people with Osteoporosis, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Whole Body Bone Mineral Content (BMC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916862, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.