Clinical trial NCT03864172: Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
Official title: Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Health
Lead sponsor: International Medical University
Sponsor class: OTHER
Collaborators: name: Tate & Lyle
First posted: 2019-03-06
Enrollment: 243
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled Trial
Primary purpose: PREVENTION

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

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Bone mineral density ( BMD)
timeFrame: 12 months
measure: Bone mineral content (BMC)
timeFrame: 12 months
Secondary outcomes:
measure: Bone biomarkers
timeFrame: 12 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: International Medical University
Study officials:
affiliation: International Medical University
name: Winnie SS Chee, PhD
role: PRINCIPAL_INVESTIGATOR
References: