Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05025917
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2021-08-11
Brief Title:
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women
Sponsor:
University of Exeter
Organization:
University of Exeter
Study Overview
Official Title:
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women A Randomised Double Blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 womens 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 bodys 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 26500 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
As shatavari may act on the bodys 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 26500 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None