Calcium Bioavailability of Cassia Leaves in Post-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Fractional calcium absorption
研究概览
简要总结
Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis. However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products. The primary goal of this study is to measure the fractional calcium absorption from milk and a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with habitually low calcium intakes. The secondary objective is to determine associations between calcium absorption and biomarkers which impact vitamin D status and bone metabolism.
详细描述
Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and Nakhon Pathon, Thailand. They will be invited to participate in an isotope study comparing the fractional calcium absorption from milk and cassia. Upon arrival, a fasting blood sample will be drawn on the morning of the absorption study to analyze serum markers of vitamin D and bone metabolism (25-hydroxy vitamin D [25OHD], parathyroid hormone [PTH], and beta-crossLaps) and to determine their impact on calcium absorption. Following this blood draw, women will receive a stable calcium isotope (42Ca) intravenously. Then for breakfast and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium isotope from either the milk (44Ca) or cassia (43Ca) test meals. On day two, women will receive a breakfast, snack, and lunch meal. Urine samples will be collected over the entire 28 hour period and the 24-hr urine collection will be used to measure urinary calcium concentration and to calculate fractional calcium absorption.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 53 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 3 years postmenopausal
排除标准
- •Diagnosed gastrointestinal or metabolic diseases known to interfere with calcium absorption and metabolism
- •Women taking medications (including thiazide diuretics, hormonal replacement therapy, etc.) within two months prior to the study
- •Women taking dietary supplements within two months prior to the study
结局指标
主要结局
Fractional calcium absorption
时间窗: 24 hours after the ingestion of the second test meal
Urine samples will be collected over s 28 hour period post-dosing with collection ending 24 hours after the ingestion of the second test meal.
次要结局
- The concentration of 25-hydroxy vitamin D (25OHD) in serum(Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.)
- The concentration of parathyroid hormone (PTH) in serum(Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.)
- The concentration of beta-crossLaps in serum(Upon entry to the study, a 10 mL blood sample will be collected in a less than 2 hour time period.)