Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
NCT ID: NCT03864172
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
243 participants
INTERVENTIONAL
2017-08-02
2019-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Usual intake + placebo fruit juice
Placebo fruit flavoured juice powder
Usual intake + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice
Usual intake +SCF fruit juice
Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)
Usual intake+SCF fruit juice
Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
Adequate calcium +fruit juice placebo
Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake
Adequate calcium + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
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
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
Interventions
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Usual intake + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice
Usual intake+SCF fruit juice
Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
Adequate calcium + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
9 Years
11 Years
ALL
Yes
Sponsors
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Tate & Lyle
INDUSTRY
IMU University, Malaysia
OTHER
Responsible Party
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Winnie Chee
Principal Investigator
Principal Investigators
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Winnie SS Chee, PhD
Role: PRINCIPAL_INVESTIGATOR
IMU University, Malaysia
Locations
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International Medical University
Kuala Lumpur, , Malaysia
Countries
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References
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Arasu K, Chang CY, Wong SY, Ong SH, Yang WY, Chong MHZ, Mavinkurve M, Khoo EJ, Chinna K, Weaver CM, Chee WSS. Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study). Osteoporos Int. 2023 Apr;34(4):783-792. doi: 10.1007/s00198-023-06702-0. Epub 2023 Feb 21.
Other Identifiers
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InternationalMU
Identifier Type: -
Identifier Source: org_study_id
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