Clinical Trials Logo
  1. Home
  2. Bone Health
  3. NCT03864172
  4. Details
NCT03864172 Clinical Trial

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

Bone Health Clinical Trial

— PREBONE-Kids  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03864172
Other study ID # InternationalMU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2017
Est. completion date August 1, 2019

Study information
Verified date August 2019
Source International Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 calcium intakes compared to placebo.

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

Recruitment information / eligibility
Status Completed
Enrollment 243
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 11 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Usual intake + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice
• Usual intake+SCF fruit juice
Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
• Adequate calcium + placebo fruit juice
Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
• Adequate 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

Locations
Country Name City State
Malaysia International Medical University Kuala Lumpur

Sponsors (2)
Lead Sponsor Collaborator
International Medical University Tate & Lyle

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral density ( BMD) BMD at total body and lumbar spine L1-L4 12 months
Primary Bone mineral content (BMC) BMC at total body and lumbar spine L1-L4 12 months
Secondary Bone biomarkers Serum CTX1, P1NP, osteocalcin & BAP 12 months
See also
  Status Clinical Trial Phase
Completed NCT02163668 - Effects of Yoga on Bone Metabolism in Premenopausal Women N/A
Completed NCT01058109 - Study of the Effect of a Calcium-rich Diet on Bone Health in Girls Phase 3
Active, not recruiting NCT05910606 - Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program. N/A
Completed NCT05658159 - Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
Completed NCT03892395 - An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health N/A
Completed NCT02928913 - The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health N/A
Completed NCT01638182 - Biocomparison Study N/A
Recruiting NCT03455868 - Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Completed NCT01617109 - Optimizing Vitamin D Status During Initial Military Training N/A
Completed NCT03956732 - Effects of Milk Protein and Vitamin D on Children's Growth and Health N/A
Enrolling by invitation NCT06351176 - Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
Completed NCT04064437 - Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
Completed NCT02636348 - Evaluation of Calcium and Vitamin D Supplementation During Marine Corps Training N/A
Completed NCT01235325 - The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients Phase 4
Active, not recruiting NCT04573946 - VITamin D and OmegA-3 TriaL: Interrelationship of Vitamin D and Vitamin K on Bone (VITAL) N/A
Recruiting NCT03533010 - Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation N/A
Completed NCT03651037 - Physical Activity Platform to Improve Bone Health in Cancer Survivors N/A
Not yet recruiting NCT03786835 - Healthy Older People Everyday (HOPE) - Role of Healthy Diet on Muscle and Bone Health N/A
Active, not recruiting NCT01747447 - VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL) N/A
Completed NCT04076618 - Incorporating Nutrition, Vests, Education, and Strength Training in Bone Health (INVEST in Bone Health) N/A