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

IMU University, Malaysia243 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

243

Conditions

Bone Health

Interventions

Usual intake + placebo fruit juiceDIETARY_SUPPLEMENT

Participants will consume 200 mls of placebo fruit flavoured juice

Usual intake+SCF fruit juiceDIETARY_SUPPLEMENT

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

Adequate calcium + placebo fruit juiceDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 9 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

International Medical University

Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Bone mineral density ( BMD)

BMD at total body and lumbar spine L1-L4

Time frame: 12 months

Bone mineral content (BMC)

BMC at total body and lumbar spine L1-L4

Time frame: 12 months

Secondary Outcomes

Bone biomarkers

Serum CTX1, P1NP, osteocalcin \& BAP

Time frame: 12 months

Data from ClinicalTrials.gov

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