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Completed

NCT Number: NCT03864172

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

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.

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Key information

Conditions

Bone Health

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Medical University

Kuala Lumpur, 57000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual intake + placebo fruit juice

Dietary Supplement

Participants will consume 200 mls of placebo fruit flavoured juice

Usual intake+SCF fruit juice

Dietary Supplement

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

Adequate calcium + placebo fruit juice

Dietary Supplement

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

Adequate calcium+ SCF fruit juice

Dietary Supplement

Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI

Primary outcomes

  1. Bone mineral density ( BMD)

    Time frame: 12 months

    BMD at total body and lumbar spine L1-L4

  2. Bone mineral content (BMC)

    Time frame: 12 months

    BMC at total body and lumbar spine L1-L4

Secondary outcomes

  1. Bone biomarkers

    Time frame: 12 months

    Serum CTX1, P1NP, osteocalcin & BAP

Sponsors and collaborators

Lead sponsor

IMU University, Malaysia

Other

Collaborators

  • Tate & Lyle

Registry information

Official study title

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

Acronym: PREBONE-Kids

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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