Clinical trial NCT02916862: Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Official title: Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: fiber
calcium absorption
bone mass
adolescents
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-09-28
Enrollment: 213
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: we are testing a fiber and calcium supplement so it is not a drug
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in bone mineral content (BMC)
timeFrame: 12 months
measure: Change in total bone mineral density (BMD)-z score
timeFrame: 12 months
Secondary outcomes:
measure: Change in vitamin D status
timeFrame: 12 months
measure: Change in serum calcium
timeFrame: 12 months
measure: Change in serum phosphate
timeFrame: 12 months
measure: Change in bone alkaline phosphatase
timeFrame: 12 months
measure: Change in parathyroid hormone (PTH)
timeFrame: 12 months
measure: Change in osteocalcin
timeFrame: 12 months
measure: Change in bone specific alkaline phosphatase
timeFrame: 12 months
measure: Change in serum creatinine
timeFrame: 12 months
measure: Change in serum carboxy-terminal collagen crosslinks (CTX)
timeFrame: 12 months
measure: Change in serum insulin growth factor 1 (IGF-I).
timeFrame: 12 months
measure: Change in urinary calcium
timeFrame: 12 months
measure: Change in urinary phosphorus
timeFrame: 12 months
measure: Change in urinary creatinine
timeFrame: 12 months
measure: Change in urinary N-telopeptide cross-links
timeFrame: 12 months
measure: Change in total BMD
timeFrame: 12 months
measure: Change in spine BMC
timeFrame: 12 months
measure: Change in body fat
timeFrame: 12 months
measure: Change in phylogenetic diversity of bacterial communities
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Flroida International University
state: Florida
Study officials:
affiliation: Department of Dietetics, College of Public Health, Florida International Univ.
name: Cristina Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
References: