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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916862
• Other study ID #: 107593
• Secondary ID: 1R01HD098589-01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Florida International University
• Contact: Cristina Palacios, PhD
• Phone: 3053483235
• Email: cristina.palacios[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

• Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Soluble Corn Fiber (SCF) without Calcium
Participants will consume a supplement with 12 g/day of SCF for 12 months

Combination Product:
• Soluble Corn Fiber (SCF) + Calcium
Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months

Dietary Supplement:
• Placebo
Participants will consume a supplement without SCF or calcium carbonate for 12 months

Combination Product:
• Placebo + calcium
Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months

Locations

Country	Name	City	State
United States	Nicklaus Childrens Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral content (BMC)	Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)	12 months
Primary	Change in total bone mineral density (BMD)-z score	Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)	12 months
Secondary	Change in vitamin D status	Vitamin D status will be measured as serum 25(OH)D at baseline and 12-months follow-up visits using standard ELISA kits.	12 months
Secondary	Change in serum calcium	Serum calcium will be measured at baseline and 12-months follow-up visits using standardized kits	12 months
Secondary	Change in serum phosphate	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in bone alkaline phosphatase	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in parathyroid hormone (PTH)	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in osteocalcin	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in bone specific alkaline phosphatase	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in serum creatinine	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in serum carboxy-terminal collagen crosslinks (CTX)	I will be measured at baseline and 12-months follow-up visits using standardized kits	12 months
Secondary	Change in serum insulin growth factor 1 (IGF-I).	It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits	12 months
Secondary	Change in urinary calcium	It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits	12 months
Secondary	Change in urinary phosphorus	It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits	12 months
Secondary	Change in urinary creatinine	It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits	12 months
Secondary	Change in urinary N-telopeptide cross-links	It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits	12 months
Secondary	Change in total BMD	Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)	12 months
Secondary	Change in spine BMC	Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)	12 months
Secondary	Change in body fat	Participants will undergo a bone scan at baseline, at 6 months and at 12-months follow-up visits using a dual energy x-ray absorptiometry (DXA)	12 months
Secondary	Change in phylogenetic diversity of bacterial communities	Participants will provide a fecal sample at baseline and at 12-months follow-up visits using 16S ribosomal RNA (or 16S rRNA) gene sequences	12 months