SCF Supplementation for Bone Health in Adolescents

(MetA-Bone Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how soluble corn fiber (SCF), with or without calcium, affects bone health in adolescents. Researchers aim to determine if adding SCF to a diet for a year influences bone growth and metabolism compared to a placebo. Participants will be divided into four groups to receive either SCF, SCF with calcium, a placebo, or a placebo with calcium. The study seeks healthy children aged 10-13 who are not taking regular medications or high doses of calcium or vitamin D supplements. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings on bone health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that soluble corn fiber (SCF) is generally safe for consumption. Studies have found that taking 12 grams of SCF daily can enhance calcium absorption and improve bone health without major side effects, indicating that SCF is usually well-tolerated. SCF has also been used to strengthen bones in teenagers and postmenopausal women, again without significant safety concerns. This trial is testing SCF both with and without added calcium, and past studies support the safety of both approaches. The trial is in an early stage, primarily focusing on ensuring safety and monitoring for any side effects in healthy volunteers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for boosting bone health in adolescents, which often focus solely on calcium supplementation, these investigational treatments include soluble corn fiber (SCF) as a key component. SCF is unique because it acts as a prebiotic, potentially enhancing calcium absorption in the gut, which could lead to stronger bones. Researchers are excited because SCF might offer a more effective and holistic approach to bone health by not only supplying necessary calcium but also improving how the body uses it. This dual-action approach sets it apart from traditional calcium supplements, which don't typically enhance calcium absorption on their own.

What evidence suggests that this trial's treatments could be effective for bone health in adolescents?

Research has shown that soluble corn fiber (SCF) can enhance calcium absorption in teenagers, benefiting bone health. This trial will test different supplementation strategies: some participants will receive SCF combined with calcium, while others will receive SCF without additional calcium. Studies have found that SCF can also increase markers of bone formation. When combined with calcium, SCF enhances calcium retention and improves overall bone health. These early findings suggest that SCF, with or without extra calcium, could be a promising approach to support bone health in young people. ^{1 4 5 6 7}

Who Is on the Research Team?

Cristina Palacios, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7484365/

Effect of Soluble Corn Fiber supplementation for 1 year on ... In conclusion, SCF supplementation has been shown to improve calcium absorption and improve bone formation biomarkers in adolescents and in adults. The evidence ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522046081

Soluble corn fiber increases bone calcium retention in ... Background: Dietary soluble corn fiber (SCF) significantly improves calcium absorption in adolescents and the bone strength and architecture in rodent models.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01571440

Soluble Corn Fiber and Calcium Utilization in Adolescents ... weight, and bone density were evaluated throughout the 6-week period of the study. Official Title. The Effect of Soluble Corn Fiber on ...

4. withpower.com withpower.com/trial/phase-3-osteoporosis-1-2020-2e770

SCF Supplementation 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32574844/

Effect of soluble corn fiber supplementation for 1 year on bone ... We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022316623006429

Soluble Corn Fiber Increases Calcium Absorption ... Soluble corn fiber (SCF; 12 g fiber/d) is shown to increase calcium absorption efficiency, associated with shifts in the gut microbiota in adolescent males and ...

7. tateandlyle.com tateandlyle.com/sites/default/files/2021-02/tate-lyle-promitor-soluble-fibrenc2021.pdf

SOLUBLE CORN FIBRE: HEALTH BENEFITS AND ... PROMITOR® Soluble Fibre may help support bone health by increasing calcium absorption and bone calcium retention while providing a source of fibre. Figure 4.