Effects of Soluble Corn Fiber on BMC, BMD and Bone Biomarkers of Pre-pubertal Boys and Girls : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Bone mineral content (BMC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind study
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual intake + placebo fruit juice
Placebo fruit flavoured juice powder
干预措施: Usual intake + placebo fruit juice (Dietary Supplement)
Usual intake +SCF fruit juice
Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)
干预措施: Usual intake+SCF fruit juice (Dietary Supplement)
Adequate calcium +fruit juice placebo
Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake
干预措施: Adequate calcium + placebo fruit juice (Dietary Supplement)
Adequate calcium + SCF fruit juice
Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake
干预措施: Adequate calcium+ SCF fruit juice (Dietary Supplement)
结局指标
主要结局
Bone mineral content (BMC)
时间窗: 12 months
BMC at total body and lumbar spine L1-L4
Bone mineral density ( BMD)
时间窗: 12 months
BMD at total body and lumbar spine L1-L4
次要结局
- Bone biomarkers(12 months)
研究者
Winnie Chee
Principal Investigator
International Medical University