SCF Supplementation for Bone Health in Adolescents

(MetA-Bone Trial)

Recruiting at 2 trial locations

Overseen By Cristina Palacios, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Florida International University

Must not be taking: Calcium, Vitamin D

Disqualifiers: Chronic illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 52 weeks

213 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 6 7 8}

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

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

Group I: Soluble Corn Fiber (SCF) + Calcium Experimental Treatment 1 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 calcium Active Control 1 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: Placebo Placebo Group 1 Intervention

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

Group IV: Placebo + calcium Placebo Group 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a 12-week study on weanling rats, certain dietary fibers, particularly soluble corn fiber and soluble fiber dextrin, significantly improved bone properties, including mineral content and density.

While the production of short-chain fatty acids (SCFA) and calcium absorption were not strongly linked to bone health benefits, the weight of cecal content suggested that other mechanisms may also play a role in enhancing bone strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel fibers increase bone calcium content and strength beyond efficiency of large intestine fermentation. Weaver, CM., Martin, BR., Story, JA., et al.[2017]

In a study involving 28 healthy adolescent females, soluble corn fiber (SCF) at doses of 10 g and 20 g per day significantly increased calcium absorption by approximately 13% compared to a control group.

The consumption of SCF also led to notable changes in the gut microbiome, with increased diversity and higher proportions of beneficial bacteria, such as Parabacteroides, which may contribute to enhanced calcium absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. Whisner, CM., Martin, BR., Nakatsu, CH., et al.[2023]

In a study involving 24 adolescents, a daily intake of 12 g of soluble maize fibre (SCF) significantly increased calcium absorption by 12% compared to a control group, suggesting that SCF can enhance calcium uptake in growing children.

The SCF treatment also led to a higher proportion of beneficial bacteria (Bacteroidetes) in the gut microbiota, indicating that SCF may positively influence gut health alongside improving calcium absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. Whisner, CM., Martin, BR., Nakatsu, CH., et al.[2017]

In a study involving 154 pre-pubertal children over 18 months, calcium supplementation did not significantly improve bone mineral density or bone size, likely due to already high dietary calcium intake among participants.

The results suggest that calcium supplementation is most beneficial for children with low habitual calcium intake, as those with adequate intake showed no additional benefits from extra calcium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a high calcium dairy food on bone health in pre-pubertal children in New Zealand. Gibbons, MJ., Gilchrist, NL., Frampton, C., et al.[2006]

In a study involving 14 postmenopausal women, daily consumption of soluble corn fiber (SCF) significantly improved bone calcium retention, with increases of 4.8% and 7% for doses of 10 g and 20 g, respectively.

The study also found that SCF consumption led to a significant increase in bone-specific alkaline phosphatase, a marker of bone formation, indicating that SCF may help improve bone health in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. Jakeman, SA., Henry, CN., Martin, BR., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Young adolescents who respond to an inulin-type fructan substantially increase total absorbed calcium and daily calcium accretion to the skeleton. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Novel fibers increase bone calcium content and strength beyond efficiency of large intestine fermentation. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Soluble Corn Fiber Increases Calcium Absorption Associated with Shifts in the Gut Microbiome: A Randomized Dose-Response Trial in Free-Living Pubertal Females. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. [2017]

7. China pubmed.ncbi.nlm.nih.gov

The effects of a high calcium dairy food on bone health in pre-pubertal children in New Zealand. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Soluble corn fiber increases bone calcium retention in postmenopausal women in a dose-dependent manner: a randomized crossover trial. [2023]