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CompletedNCT03864172PREBONE-KidsUpdated Aug 9, 2019

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

An interventional study of Usual intake + placebo fruit juice and Usual intake+SCF fruit juice in Bone Health, sponsored by International Medical University. Completed at 1 site in Malaysia. Open to participants aged 9 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-09.

Sponsored by International Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Aug 2017, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
243
Allocation
Randomized
Ages
9 Years to 11 Years
Sex
All
01

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.

Read the 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

02

Conditions studied

  • Bone Health
03

In context

Lead sponsor

International Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Screened to be generally healthy as determined by standard medical assessment on physical and mental health
  • Tanner stage 2 based on breast development for girls, and pubic hair in boys. Girls will have to be premenarcheal
  • Having obtained his/her informed consent and parents or legal guardians consent

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
243 participants (actual)

Study arms

  • Placebo comparator
    Usual intake + placebo fruit juice

    Placebo fruit flavoured juice powder

    Dietary Supplement: Usual intake + placebo fruit juice

  • Active comparator
    Usual intake +SCF fruit juice

    Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)

    Dietary Supplement: Usual intake+SCF fruit juice

  • Active comparator
    Adequate calcium +fruit juice placebo

    Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake

    Dietary Supplement: Adequate calcium + placebo fruit juice

  • Active comparator
    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

    Dietary Supplement: Adequate calcium+ SCF fruit juice

Interventions

  • Dietary supplementUsual intake + placebo fruit juice

    Participants will consume 200 mls of placebo fruit flavoured juice

  • Dietary supplementUsual intake+SCF fruit juice

    Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)

  • Dietary supplementAdequate calcium + placebo fruit juice

    Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI

  • Dietary supplementAdequate 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

06

What researchers measure

Primary outcomes

  1. Bone mineral density ( BMD)

    BMD at total body and lumbar spine L1-L4

    Time frame: 12 months

  2. Bone mineral content (BMC)

    BMC at total body and lumbar spine L1-L4

    Time frame: 12 months

Secondary outcomes

  1. Bone biomarkers

    Serum CTX1, P1NP, osteocalcin \& BAP

    Time frame: 12 months

07

Study locations

1 site
  • International Medical University
    Kuala Lumpur, 57000, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03864172
Lead sponsor
International Medical University
Collaborators
Tate & Lyle
Responsible party
Winnie Chee (Principal Investigator, International Medical University) — Principal investigator
First posted
Mar 6, 2019
Start date
Aug 2, 2017
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Aug 9, 2019

Study contacts

Winnie SS Chee, PhD
principal investigator · International Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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