213 Participants Needed

SCF Supplementation for Bone Health in Adolescents

(MetA-Bone Trial)

Recruiting at 2 trial locations
CP
Overseen ByCristina Palacios, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Florida International University
Prior Safety DataThis treatment has passed at least one previous human 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?

Research shows that Soluble Corn Fiber (SCF) can increase calcium absorption in adolescents, which is important for bone health. A study found that SCF increased calcium absorption efficiency in pubertal females, suggesting it may help improve bone mineral content and density.12345

Is soluble corn fiber (SCF) safe for human consumption?

Soluble corn fiber (SCF) is generally considered safe for human consumption, as studies have shown it to be well-tolerated in adolescents and associated with increased calcium absorption without adverse effects.12456

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

CP

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

My BMI is within the healthy range for my age and sex according to CDC charts.

Exclusion Criteria

I regularly take more than 500 mg of calcium and more than 400 IU of vitamin D daily.
I take regular medication for a chronic illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive soluble corn fiber (SCF) supplementation for 1 year to assess its effects on bone metabolism

52 weeks
Baseline, 6 months, 12 months (in-person); 3 and 9 months (home visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Placebo + calcium
  • Soluble Corn Fiber (SCF) + Calcium
  • Soluble Corn Fiber (SCF) without Calcium
Trial Overview The study tests if adding Soluble Corn Fiber (SCF), alone or with calcium, affects bone metabolism in adolescents compared to a placebo. Participants are randomly assigned into four groups: SCF only, SCF plus calcium, placebo only, and placebo plus calcium; taken twice daily for one year.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Soluble Corn Fiber (SCF) + CalciumExperimental Treatment1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group II: Soluble Corn Fiber (SCF) without calciumActive Control1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group III: PlaceboPlacebo Group1 Intervention
This group will receive a similar supplement without SCF or calcium, administered twice a day
Group IV: Placebo + calciumPlacebo Group1 Intervention
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials
114
Recruited
19,400+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

Findings from Research

A one-year study involving 240 healthy children aged 10-13 will assess the impact of soluble corn fiber (SCF) supplementation on bone mass and biomarkers, aiming to improve bone health in adolescents with low calcium intake.
The study will compare SCF alone and SCF with additional calcium against placebo groups, using dual energy x-ray absorptiometry (DXA) to measure bone density and serum biomarkers to evaluate bone formation and resorption, potentially leading to stronger bones in adulthood.
Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.Palacios, C., Trak-Fellermeier, MA., Pérez, CM., et al.[2021]
In a study involving 243 preadolescent children, soluble corn fibre (SCF) combined with calcium showed initial improvements in bone mineral content after 6 months, but these benefits did not persist at 12 months, indicating limited long-term efficacy.
Calcium supplementation alone improved bone mineral density at 6 months, but by 12 months, there were no significant differences in bone indices among the groups, suggesting that while calcium may have short-term benefits, SCF did not contribute to sustained improvements in bone health.
Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study).Arasu, K., Chang, CY., Wong, SY., et al.[2023]
Young adolescents who consumed 8 g/d of Synergy, a mixture of inulin-type fructans, showed greater calcium absorption and bone mineral content compared to those who received a maltodextrin control, indicating its efficacy in enhancing bone health.
Among the participants, 32 were identified as responders who significantly increased their calcium absorption, leading to a notable increase in skeletal calcium accretion over a year, comparable to an additional daily intake of 250 mg of calcium.
Young adolescents who respond to an inulin-type fructan substantially increase total absorbed calcium and daily calcium accretion to the skeleton.Abrams, SA., Griffin, IJ., Hawthorne, KM.[2023]

References

Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design. [2021]
Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study). [2023]
Young adolescents who respond to an inulin-type fructan substantially increase total absorbed calcium and daily calcium accretion to the skeleton. [2023]
Novel fibers increase bone calcium content and strength beyond efficiency of large intestine fermentation. [2017]
Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. [2023]
Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. [2017]
The effects of a high calcium dairy food on bone health in pre-pubertal children in New Zealand. [2006]
Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. [2023]
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