Bone Health Clinical Trial
Official title:
Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial
The aim of this study is to investigate the effects of soluble corn fiber (SCF) on bone mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls. The hypothesis to be tested is: SCF will lead to greater increase of BMD, as measured with densitometry in both low calcium as well as high calcium intakes compared to placebo.
Main objective To investigate the effects of soluble corn fiber (SCF) supplementation on bone
mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls.
Secondary objectives
The secondary objectives are:
To investigate changes in bone formation and bone resorption markers in response to soluble
corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate
calcium intake vs placebo To investigate changes in body composition in response to soluble
corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate
calcium intake vs placebo
Hypothesis Soluble corn fiber would lead to improved BMC and BMD accrual in pre-pubertal
children compared to placebo.
Study design The proposed study is a double blind, randomized, single center, parallel design
trial
Duration of study The duration of the study intervention would be 12 months
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