Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents (MetA-Bone)

Florida International University (FIU)

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Combination Product: Placebo + calcium; Dietary Supplement: Placebo; Combination Product: Soluble Corn Fiber (SCF) + Calcium; Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02916862

107593

1R01HD098589-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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177 participants in 4 patient groups, including a placebo group

Soluble Corn Fiber (SCF) + Calcium

Experimental group

Description:

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

Treatment:

Combination Product: Soluble Corn Fiber (SCF) + Calcium

Soluble Corn Fiber (SCF) without calcium

Active Comparator group

Description:

This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day

Treatment:

Dietary Supplement: Soluble Corn Fiber (SCF) without Calcium

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Placebo + calcium

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Placebo + calcium