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

Not Applicable

Completed

• Conditions: Bone Health
• Interventions: Dietary Supplement: Usual intake + placebo fruit juice; Dietary Supplement: Adequate calcium+ SCF fruit juice; Dietary Supplement: Usual intake+SCF fruit juice; Dietary Supplement: Adequate calcium + placebo fruit juice

• Registration Number: NCT03864172
• Lead Sponsor: International Medical University

Brief 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

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

Not provided

Exclusion Criteria

• History of serious medical conditions such as intestinal or severe metabolic diseases, disorders such as diabetes, renal, hepatic or pancreatic diseases, disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition, anaemia
• History or on therapy with medication known to interfere with bone metabolism such as steroids, hormones, diuretics, cortisone or anti-seizure medication
• Taking regularly any nutritional supplements and unwilling to stop for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual intake + placebo fruit juice	Usual intake + placebo fruit juice	Placebo fruit flavoured juice powder
Adequate calcium + SCF fruit juice	Adequate calcium+ SCF fruit juice	Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake
Usual intake +SCF fruit juice	Usual intake+SCF fruit juice	Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)
Adequate calcium +fruit juice placebo	Adequate calcium + placebo fruit juice	Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake

Primary Outcome Measures

Name	Time	Method
Bone mineral density ( BMD)	12 months	BMD at total body and lumbar spine L1-L4
Bone mineral content (BMC)	12 months	BMC at total body and lumbar spine L1-L4

Secondary Outcome Measures

Name	Time	Method
Bone biomarkers	12 months	Serum CTX1, P1NP, osteocalcin \& BAP

Trial Locations

Locations (1)

International Medical University; 🇲🇾 Kuala Lumpur, Malaysia