Resveratrol for the Prevention of Bone Loss in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Bone biomarker
研究概览
简要总结
The purpose of this study is to examine whether daily supplementation of resveratrol would improve bone health in postmenopausal women.
详细描述
We plan to enroll and screen 68 women, with an estimated 34 qualifying women will be randomly assigned to two groups: 1) the placebo group and 2) the resveratrol group. The resveratrol group will receive 500 mg resveratrol daily for 24 weeks, and placebo group will receive placebo pills. Both groups will receive 500 mg calcium plus 400 IU vitamin D daily.
Blood and urinary biomarkers of bone metabolism will be assessed at baseline and after 12 and 24 weeks intervention. Bone mineral density will be assessed using dual-energy X-ray absorptiometry at baseline and after 24 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1 to 10 years postmenopausal women with low bone mass
排除标准
- •Osteoporosis
- •Taking blood thinners, endocrine, or neuroactive drugs
- •Hormone therapy
- •Diagnosed: Metabolic bone disease, renal disease, kidney stones, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease
- •Severe menopausal symptoms, serious mood alterations, sleep disturbances
- •Abnormal uterine bleeding, endometriosis, pelvic inflammatory disease
- •Endometrial polyps, and significant uterine fibroids
- •Smokers (≥ 20 cigarettes per day)
- •BMI <20 and > 30 kg/m2
- •Intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine, or blueberries
研究组 & 干预措施
Placebo
Dietary Supplement: Placebo (500 mg) + 500 mg calcium and 400 IU vitamin D3
干预措施: Placebo (Dietary Supplement)
Resveratrol
Dietary Supplement: Resveratrol (500 mg) + 500 mg calcium and 400 IU vitamin D3
干预措施: Resveratrol (Dietary Supplement)
结局指标
主要结局
Bone biomarker
时间窗: Bone marker will be assessed before and after 12 weeks and 24 weeks intervention
25-hydroxy vitamin D3
次要结局
- Bone mineral density(Bone mineral density will be assessed before and after 24 weeks intervention)