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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Health
• Intervention / Treatment: 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

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

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 57000
    • International Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual intake + placebo fruit juice; Placebo fruit flavoured juice powder	Dietary supplement: Usual intake + placebo fruit juice; Participants will consume 200 mls of placebo fruit flavoured 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; Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
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; Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
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; Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: International Medical University
• Collaborators: Tate & Lyle
• Investigators: Principal Investigator: Winnie SS Chee, PhD, International Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: InternationalMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No