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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial

Conditions
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Bone Health

Intervention / Treatment
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* Dietary Supplement: Usual intake + placebo fruit juice
* Dietary Supplement: Usual intake+SCF fruit juice
* Dietary Supplement: Adequate calcium + placebo fruit juice
* Dietary Supplement: Adequate calcium+ SCF fruit juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual intake + placebo fruit juice<br>Placebo fruit flavoured juice powder | Dietary Supplement: Usual intake + placebo fruit juice<br>* Participants will consume 200 mls of placebo fruit flavoured juice<br>|
| Active Comparator: Usual intake +SCF fruit juice<br>Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) | Dietary Supplement: Usual intake+SCF fruit juice<br>* Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)<br>|
| Active Comparator: Adequate calcium +fruit juice placebo<br>Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake | Dietary Supplement: Adequate calcium + placebo fruit juice<br>* Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI<br>|
| Active Comparator: Adequate calcium + SCF fruit juice<br>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<br>* Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density ( BMD) | BMD at total body and lumbar spine L1-L4 | 12 months | 
| Bone mineral content (BMC) | BMC at total body and lumbar spine L1-L4 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone biomarkers | Serum CTX1, P1NP, osteocalcin & BAP | 12 months |