Hesperidin and Bone Health in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Elimination of 41Calcium in Urine.
研究概览
简要总结
The primary objective of this clinical trial is to test hesperidin with and without CALCILOCK® for bone resorption suppressing effect in postmenopausal women. The secondary objective is the comparison between 41Ca technology and classical biomarker to evaluate bone resorption.
详细描述
Subjects will participate in four phases of the study: Baseline of 50 days and three intervention phases which include 50 days receiving product followed by 50 days of recovery. The total duration of the study will be 350 days. If participant has not been previously labeled with 41Ca, a 150 day period is added to the study.
Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at least 4 years postmenopausal
排除标准
- •Medications affecting bone resorption
研究组 & 干预措施
Hesperidin and Calcilock
Subjects will consume 4 cookies containing Hesperidin and Calcilock.
干预措施: Hesperidin and Calcilock (Dietary Supplement)
Control
Subjects will consume 4 cookies daily without Hesperidin or Calcilock.
干预措施: Control (Dietary Supplement)
Hesperidin
Subjects will consume 4 cookies containing Hesperidin, 552mg, daily
干预措施: Hesperidin (Dietary Supplement)
结局指标
主要结局
Elimination of 41Calcium in Urine.
时间窗: 50 days
Appearance of Ca41 in urine will be measured by Accelerator Mass Spectrometry to represent calcium that is being lost from the skeleton.
次要结局
未报告次要终点
研究者
Berdine Martin
Research Scientist
Purdue University