Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tate & Lyle | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual intake + placebo fruit juice | Placebo Comparator | Placebo fruit flavoured juice powder |
|
| Usual intake +SCF fruit juice | Active Comparator | Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) |
|
| Adequate calcium +fruit juice placebo | Active Comparator | Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake |
|
| Adequate calcium + SCF fruit juice | Active Comparator | Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual intake + placebo fruit juice | Dietary Supplement | Participants will consume 200 mls of placebo fruit flavoured juice |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bone biomarkers | Serum CTX1, P1NP, osteocalcin & BAP | 12 months |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Winnie SS Chee, PhD | IMU University, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | 57000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36808216 | Derived | Arasu K, Chang CY, Wong SY, Ong SH, Yang WY, Chong MHZ, Mavinkurve M, Khoo EJ, Chinna K, Weaver CM, Chee WSS. Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study). Osteoporos Int. 2023 Apr;34(4):783-792. doi: 10.1007/s00198-023-06702-0. Epub 2023 Feb 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomised controlled Trial
Not provided
Not provided
Double blind study
| 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 |
|