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.