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

International Medical University

Status: Completed

Conditions: Bone Health

Treatments: Dietary Supplement: Adequate calcium + placebo fruit juice; Dietary Supplement: Adequate calcium+ SCF fruit juice; Dietary Supplement: Usual intake + placebo fruit juice; Dietary Supplement: Usual intake+SCF fruit juice

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03864172

InternationalMU

Details and patient eligibility

About

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.

Full 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

Enrollment: 243 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 4 patient groups, including a placebo group

Usual intake + placebo fruit juice

Placebo Comparator group

Description:

Placebo fruit flavoured juice powder

Treatment:

Dietary Supplement: Usual intake + placebo fruit juice

Usual intake +SCF fruit juice

Active Comparator group

Description:

Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)

Treatment:

Dietary Supplement: Usual intake+SCF fruit juice

Adequate calcium +fruit juice placebo

Active Comparator group

Description:

Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake

Treatment:

Dietary Supplement: Adequate calcium + placebo fruit juice

Adequate calcium + SCF fruit juice

Active Comparator group

Description:

Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake

Treatment:

Dietary Supplement: Adequate calcium+ SCF fruit juice