Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
- Conditions
- Osteoporosis
- Interventions
- Combination Product: Soluble Corn Fiber (SCF) + CalciumCombination Product: Placebo + calciumDietary Supplement: Soluble Corn Fiber (SCF) without CalciumDietary Supplement: Placebo
- Registration Number
- NCT02916862
- Lead Sponsor
- Florida International University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- Body mass index between the 5th and 85th percentiles for age and sex based on the Centers for Disease Control Growth Charts.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Soluble Corn Fiber (SCF) + Calcium 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 Placebo + calcium Placebo + calcium This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day Soluble Corn Fiber (SCF) without calcium 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 Placebo Placebo This group will receive a similar supplement without SCF or calcium, administered twice a day
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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 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 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 serum calcium 12 months Serum calcium will be measured at baseline and 12-months follow-up visits 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 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 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 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 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 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 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
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 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
Trial Locations
- Locations (1)
Flroida International University
🇺🇸Miami, Florida, United States