Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
研究概览
简要总结
The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female with osteopenia (T-score between -1.0 and -2.5)
- •at least 18 years of age
- •must be willing to drink tea three times a day for 3 months
- •must also be willing to come to the study location on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3),
- •must also be willing to come to the study location to provide urinary, salivary and fecal samples on 2 occasions (baseline and at the end of month 3),
- •must also be willing to come to the study location to have their blood pressure taken on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3)
- •must be willing to come to the study location to complete questionnaires on 2 occasions (baseline and at the end of month 3)
- •must be willing to maintain daily diary for 4 months.
排除标准
- •Women or men with osteoporosis
- •Women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use
- •Women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators, hormone therapy, teriparatide, and denosumab)
- •Women or men with chronic obstructive pulmonary disease (COPD)
- •Women or men who smoke
结局指标
主要结局
The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
时间窗: 3 months
Urinary CTx levels will be measured at times month 0 (baseline) and month 3
The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP
时间窗: 3 months
Urinary CTx:P1NP levels will be measured at times month 0 (baseline) and month 3
The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels
时间窗: 3 months
Urinary P1NP levels will be measured at times month 0 (baseline) and month 3
次要结局
未报告次要终点
研究者
Paula Witt-Enderby
Professor of Pharmacology
Duquesne University