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Dietary Supplement

SCF Supplementation for Bone Health in Adolescents

Phase 2

Recruiting

Led By Cristina Palacios, PhD

Research Sponsored by Florida International University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will study the effects of soluble corn fiber (SCF) supplementation on bone metabolism in growing adolescents compared to controls, by administering SCF or a placebo to adolescents aged 10-13 years, and assessing bone mass, bone related biomarkers, and the fecal microbiome at baseline and after 12 months.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves dietary supplementation rather than drugs, side effects may be minimal but could include gastrointestinal discomfort such as bloating or gas due to fiber intake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in bone mineral content (BMC)

Change in total bone mineral density (BMD)-z score

Secondary outcome measures

Change in body fat

Change in bone alkaline phosphatase

Body Weight Changes

+15 more

Trial Design

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: Placebo + calciumPlacebo Group1 Intervention

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

Group IV: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Florida International UniversityLead Sponsor

99 Previous Clinical Trials

17,065 Total Patients Enrolled

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

1,964 Previous Clinical Trials

2,674,490 Total Patients Enrolled

13 Trials studying Osteoporosis

4,151 Patients Enrolled for Osteoporosis

Cristina Palacios, PhDPrincipal Investigator - Department of Dietetics, College of Public Health, Florida International Univ.

Florida International University

2 Previous Clinical Trials

240 Total Patients Enrolled

Media Library

Osteoporosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT02916862 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have the regulatory authorities declared Soluble Corn Fiber (SCF) + Calcium to be safe for public consumption?

"After careful evaluation, our team at Power assessed Soluble Corn Fiber (SCF) + Calcium's safety as a 2. This is because the Phase 2 trial has evidence of its security but not proof of efficacy."

Answered by AI

In what ways is Soluble Corn Fiber (SCF) + Calcium typically employed?

"Soluble Corn Fiber (SCF) in combination with Calcium is commonly dispensed to patients suffering from renal failure. Additionally, it can be beneficial for those enduring joint discomfort, osteodystrophy or hypoparathyroidism."

Answered by AI

Is this investigation still recruiting participants?

"That is correct. According to clinicaltrials.gov, the trial in question began recruitment on February 10th 2020 and was last modified May 11th 2022. The study requires 240 participants from a single location."

Answered by AI

How many participants are currently enrolled in this trial?

"Yes, the information available on clinicaltrials.gov points to this trial currently being open for recruitment. It was initially posted on February 10th 2020 and most recently updated on May 11th 2022; with a goal of enrolling 240 participants at one site."

Answered by AI

What previous research has been conducted concerning the combination of Soluble Corn Fiber (SCF) and Calcium?

"Currently, 48 separate investigations regarding the effects of Soluble Corn Fiber (SCF) + Calcium have been launched with 17 reaching Phase 3. Most trials for this combination are located in Shanghai but there are 6451 research sites around the world conducting studies related to SCF and calcium."

Answered by AI

Does this trial include elderly participants who are older than 75 years of age?

"This clinical trial is specifically recruiting participants aged 10 to 13. Of the 182 studies, 34 are for minors and 148 target adults over 65 years of age."

Answered by AI

What results is this investigation seeking to attain?

"This clinical trial will assess participants' Change in bone mineral content (BMC) as the primary outcome over the course of 12 months. Secondary outcomes that are to be monitored include alterations in Vitamin d status, serum 25(OH)D levels at baseline and follow-up visits via ELISA kits, changes in Bone Specific Alkaline Phosphatase measured from a serum sample with standardised kits, and urinary Creatinine evaluated using 24-h urine samples also assessed through standardized kits."

Answered by AI

Who fulfills the criteria to participate in this experiment?

"This study is seeking 240 participants with osteoporosis between the ages of 10 and 13. To qualify, patients must meet a few prerequisites; in particular, their Body Mass Index should be within the 5th to 85th percentile based on Centers for Disease Control Growth Charts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Cristina Palacios, PhD 2020. "Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02916862.

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