Bone Health
Conditions
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 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
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
Interventions
DIETARY_SUPPLEMENTUsual intake + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice
DIETARY_SUPPLEMENTUsual intake+SCF fruit juice
Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
DIETARY_SUPPLEMENTAdequate calcium + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
DIETARY_SUPPLEMENTAdequate 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
Sponsors
Tate & Lyle
IMU University, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind study
Intervention model description
Randomised controlled Trial
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density ( BMD) | 12 months | BMD at total body and lumbar spine L1-L4 |
| Bone mineral content (BMC) | 12 months | BMC at total body and lumbar spine L1-L4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone biomarkers | 12 months | Serum CTX1, P1NP, osteocalcin & BAP |
Countries
Malaysia
Outcome results
None listed