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

NCT03864172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2019-08-09

No results posted yet for this study

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.

Conditions

  • Bone Health

Interventions

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

Sponsors & Collaborators

  • Tate & Lyle

    collaborator INDUSTRY

  • IMU University, Malaysia

    lead OTHER

Principal Investigators

  • Winnie SS Chee, PhD · IMU University, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2019-08-01
Completion
2019-08-01

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864172 on ClinicalTrials.gov