Milk and Yogurt vs. Calcium and Vitamin D Supplements for Bone Health of Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ratio of 41Ca/40Ca excreted in urine
研究概览
简要总结
Does the consumption of dairy foods reduce the rate of bone loss in older women more than calcium and vitamin D supplements.
详细描述
Research indicates that bone health is dependent on multiple nutrients, not just calcium and vitamin D, leading to the conclusion that calcium from sources that include other bone enhancing nutrients may be more effective in maintaining bone integrity than calcium and vitamin D supplements. Several studies have examined the effects of calcium intake from dairy foods on different indicators of bone health. Reducing the rate of bone loss in postmenopausal women can reduce the risk of osteoporosis related fractures. Therefore we propose to study the effectiveness of 4 servings of milk and yogurt per day for 42 days compared to calcium and vitamin D supplements for 42 days to reduce calcium loss from the skeleton in post menopausal women. Postmenopausal women, approximately 50-65 years of age, will be studied. Each volunteer will receive both interventions in a cross-over design, in random order, separated by a 42 day washout period.
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
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Minimum 24 months since last menses
- •No hormone therapy in the past 12 months
- •Weight stable for the past 3 months
- •Bone density T score -1.7 to 0.0
- •No more than two dairy servings per day
- •No history of inflammatory disorders
- •No history of non-traumatic bone fracture
- •No supplement use or willing to discontinue
- •No lactose intolerance
- •Willing to consume milk and yogurt
排除标准
- •Less than 24 months since last menses
- •Use of hormone therapy in past yr
- •> 5 pound weight change in past 3 months
- •Osteoporosis
- •Regular >2 servings/d of dairy
- •Auto-immune/inflammatory disorders
- •History of non-traumatic bone fracture
- •Unwilling to discontinue supplements
- •Lactose intolerance
- •Unwilling to eat yogurt or drink milk
研究组 & 干预措施
Arm 1
Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days
干预措施: Intervention I (Other)
Arm 1
Four servings of dairy foods per day for 42 days, followed by washout for 42 days, followed by dietary supplements for 42 days
干预措施: Intervention II (Dietary Supplement)
Arm 2
Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.
干预措施: Intervention I (Other)
Arm 2
Dietary Supplements for 42 days, followed by washout for 42 days, followed by 4 servings of dairy foods for 42 days.
干预措施: Intervention II (Dietary Supplement)
结局指标
主要结局
Ratio of 41Ca/40Ca excreted in urine
时间窗: Days 0, 90, 120, 150, 180, 187, 194, 201, 208, 215, 222, 229, 236, 243, 250, 257, 264,271, 278, 285, 292, 299, and 306 of the study
Subjects will be asked to collect 24 hour urine samples to establish each individual's kinetic profile of Ca excretion and to measure the effectiveness of the interventions.
次要结局
未报告次要终点