Status:
COMPLETED
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
Lead Sponsor:
IMU University, Malaysia
Collaborating Sponsors:
Tate & Lyle
Conditions:
Bone Health
Eligibility:
All Genders
9-11 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT03864172
Start Date
August 2 2017
End Date
August 1 2019
Last Update
August 9 2019
Active Locations (1)
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1
International Medical University
Kuala Lumpur, Malaysia, 57000