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

Sponsor

Florida International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02916862

Collaborator

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

240

Enrollment

Location

Arms

49.6

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium Combination Product: Soluble Corn Fiber (SCF) + Calcium Dietary Supplement: Placebo Combination Product: Placebo + calcium	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

we are testing a fiber and calcium supplement so it is not a drugwe are testing a fiber and calcium supplement so it is not a drug

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 10, 2020

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Soluble Corn Fiber (SCF) + Calcium This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day	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
Active Comparator: Soluble Corn Fiber (SCF) without calcium This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day	Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium Participants will consume a supplement with 12 g/day of SCF for 12 months
Placebo Comparator: Placebo This group will receive a similar supplement without SCF or calcium, administered twice a day	Dietary Supplement: Placebo Participants will consume a supplement without SCF or calcium carbonate for 12 months
Placebo Comparator: Placebo + calcium This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day	Combination Product: Placebo + calcium Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months

Outcome Measures

Primary Outcome Measures

Change in bone mineral content (BMC) [12 months]
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)
Change in total bone mineral density (BMD)-z score [12 months]
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)

Secondary Outcome Measures

Change in vitamin D status [12 months]
Vitamin D status will be measured as serum 25(OH)D at baseline and 12-months follow-up visits using standard ELISA kits.
Change in serum calcium [12 months]
Serum calcium will be measured at baseline and 12-months follow-up visits using standardized kits
Change in serum phosphate [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in bone alkaline phosphatase [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in parathyroid hormone (PTH) [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in osteocalcin [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in bone specific alkaline phosphatase [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in serum creatinine [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in serum carboxy-terminal collagen crosslinks (CTX) [12 months]
I will be measured at baseline and 12-months follow-up visits using standardized kits
Change in serum insulin growth factor 1 (IGF-I). [12 months]
It will be measured at baseline and 12-months follow-up visits from a serum sample using standardized kits
Change in urinary calcium [12 months]
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary phosphorus [12 months]
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary creatinine [12 months]
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in urinary N-telopeptide cross-links [12 months]
It will be measured at baseline and 12-months follow-up visits from a 24-h urine sample using standardized kits
Change in total BMD [12 months]
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)
Change in spine BMC [12 months]
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)
Change in body fat [12 months]
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)
Change in phylogenetic diversity of bacterial communities [12 months]
Participants will provide a fecal sample at baseline and at 12-months follow-up visits using 16S ribosomal RNA (or 16S rRNA) gene sequences

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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