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临床试验/NCT05025917
NCT05025917已完成不适用

Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women: A Randomised Double Blind Clinical Trial

University of Exeter2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.

研究概览

简要总结

Shatavari is a plant that grows in Nepal, Sri Lanka, India and the Himalayas and its root has long been used in Ayurvedic medicine. Its traditional uses include supporting women's health, particularly during breastfeeding and during the perimenopausal period. Shatavari has been found to contain substances that have similar chemical properties to estrogen. A decrease in the amount of ovarian estrogen production causes the menopause and this reduction in circulating estrogen has widespread effects, including promoting a decrease in bone density. This increases the risk of bone fractures. Having less oestrogen is also thought to contribute to a loss of muscle strength in postmenopausal women.

As shatavari may act on the body's tissues in a similar way to estrogen, shatavari supplementation may represent one way of preventing postmenopausal bone and muscle loss. This study will investigate these questions. 24 healthy postmenopausal women aged 60 years or older will be recruited. The participants will be randomly assigned to consume shatavari (1000 mg per day, equivalent to 26,500 mg per day fresh weight shatavari) or placebo (1000 mg per day magnesium stearate) for 6 weeks. Handgrip and knee extensor strength will be measured at baseline and at 6 weeks. Vastus lateralis (VL) muscle biopsy samples will be obtained at baseline and at 6 weeks and analysed for markers of muscle function and protein turnover. Plasma and serum samples will be collected via venepuncture and markers of bone turnover (P1NP, β-CTX) will be measured at baseline and at 6 weeks. Primary human osteoblasts (not obtained from these participants) will be stimulated with pooled sera from the placebo and shatavari supplementation conditions to assess markers of osteoblast (bone-building) activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women (Last menstrual period > 12 months ago)
  • Aged 60 years or older

排除标准

  • Diagnosis (DEXA t-score < -2.5) and/or treatment for the prevention of osteoporosis, including treatmeat with bisphosphonates and non-bisphosphonates (including, but not limited to raloxifene, denosumab, teriparatide, calcitriol and estrogenic hormone replacement therapy).
  • Currently taking estrogenic hormone replacement therapy or history of estrogenic hormone replacement therapy in the past 5 years via any route of administration apart from vaginal.
  • PAR-Q+ screening indicates physical activity is unsuitable.

结局指标

主要结局

Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.

时间窗: Change from baseline myogenin expression at 6 weeks.

Measured via immunoblotting.

次要结局

  • Change in plasma concentration of markers of bone turnover.(Change from baseline concentration at 6 weeks.)
  • Change in plasma concentration of markers of inflammation.(Change from baseline concentration at 6 weeks.)
  • Change in handgrip strength.(Change from baseline strength at 6 weeks.)
  • Change in isometric knee extensor strength(Change from baseline strength at 6 weeks.)
  • Change in isokinetc knee extensor strength(Change from baseline strength at 6 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary O'Leary

Research Fellow

University of Exeter

研究点 (2)

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