Bone HealthPREBONE-KidsNCT03864172
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
A study testing Usual intake+SCF fruit juice and Adequate calcium+ SCF fruit juice in people with Bone Health, run by IMU University, Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- What is being tested?
- Usual intake+SCF fruit juice and Adequate calcium+ SCF fruit juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Aug 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Bone Health
- Being tested
- Usual intake + placebo fruit juice, Usual intake+SCF fruit juice, Adequate calcium + placebo fruit juice, Adequate calcium+ SCF fruit juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual intake + placebo fruit juiceDietary supplement
Participants will consume 200 mls of placebo fruit flavoured juice
Usual intake+SCF fruit juiceDietary supplement
Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
Adequate calcium + placebo fruit juiceDietary supplement
Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
Adequate calcium+ SCF fruit juiceDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Usual intake + placebo fruit juice | Placebo comparator | Placebo fruit flavoured juice powder Receives: Dietary Supplement: Usual intake + placebo fruit juice |
| Usual intake +SCF fruit juice | Active comparator | Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) Receives: Dietary Supplement: Usual intake+SCF fruit juice |
| Adequate calcium +fruit juice placebo | Active comparator | Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake Receives: Dietary Supplement: Adequate calcium + placebo fruit juice |
| 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 Receives: Dietary Supplement: Adequate calcium+ SCF fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density ( BMD)
BMD at total body and lumbar spine L1-L4
Measured: 12 months
Bone mineral content (BMC)
BMC at total body and lumbar spine L1-L4
Measured: 12 months
Secondary outcomes (1)
Bone biomarkers
Serum CTX1, P1NP, osteocalcin \& BAP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start2 Aug 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMU University, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Tate & Lyle
- Responsible party
- Principal investigator, Winnie Chee, IMU University, Malaysia
- Investigators
- Winnie SS Chee, PhD, Principal investigator, IMU University, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864172
- Sponsor's protocol ID
- InternationalMU
- Acronym
- PREBONE-Kids
- Status last verified
- Aug 2019
- First submitted
- 4 Mar 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36808216
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03864172
- Acronym / sponsor ID
- PREBONE-Kids / InternationalMU
- Conditions
- Bone Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- IMU University, MalaysiaUniversity, hospital or other
- Collaborators
- Tate & Lyle
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Usual intake + placebo fruit juice | Placebo comparator | Dietary Supplement: Usual intake + placebo fruit juicePlacebo fruit flavoured juice powder |
| Usual intake +SCF fruit juice | Active comparator | Dietary Supplement: Usual intake+SCF fruit juiceFruit flavoured juice powder added with 12 g soluble corn fiber (SCF) |
| Adequate calcium +fruit juice placebo | Active comparator | Dietary Supplement: Adequate calcium + placebo fruit juicePlacebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake |
| Adequate calcium + SCF fruit juice | Active comparator | Dietary Supplement: Adequate calcium+ SCF fruit juiceFruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual intake + placebo fruit juiceParticipants will consume 200 mls of placebo fruit flavoured juice | Dietary supplement | Usual intake + placebo fruit juice |
| Usual intake+SCF fruit juiceParticipants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) | Dietary supplement | Usual intake +SCF fruit juice |
| Adequate calcium + placebo fruit juiceParticipants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI | Dietary supplement | Adequate calcium +fruit juice placebo |
| Adequate calcium+ SCF fruit juiceParticipants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI | Dietary supplement | Adequate calcium + SCF fruit juice |
Primary outcome
Bone mineral density ( BMD)
Time frame: 12 months
BMD at total body and lumbar spine L1-L4
Bone mineral content (BMC)
Time frame: 12 months
BMC at total body and lumbar spine L1-L4
1 secondary outcome
Bone biomarkers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Derived from this study: PubMed 36808216Arasu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie SS Chee, PhD principal investigator
IMU University, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual intake+SCF fruit juice and Adequate calcium+ SCF fruit juice in people with Bone Health, run by IMU University, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density ( BMD) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.