NCT03864172

Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)

Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: IMU University, Malaysia · Academic / Other
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Bone Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Usual intake + placebo fruit juice	Participants will consume 200 mls of placebo fruit flavoured juice
DIETARY_SUPPLEMENT	Usual intake+SCF fruit juice	Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
DIETARY_SUPPLEMENT	Adequate calcium + placebo fruit juice	Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
DIETARY_SUPPLEMENT	Adequate calcium+ SCF fruit juice	Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI

Timeline

• Start date: 2017-08-02
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2019-03-06
• Last updated: 2019-08-09

Locations

1 site across 1 country: Malaysia