Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025917
• Other study ID #: 190206/B/01
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: August 2021
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women (Last menstrual period > 12 months ago)

• Aged 60 years or older

Exclusion Criteria:

• BMI = 30

• 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.

Related Conditions & MeSH terms

• Muscle Weakness
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Dietary Supplement:
• Shatavari
Shatavari root powder
• Magnesium stearate
Magnesium stearate powder

Locations

Country	Name	City	State
United Kingdom	Deparment of Sport and Health Sciences	Exeter	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.	Measured via immunoblotting.	Change from baseline myogenin expression at 6 weeks.
Secondary	Change in plasma concentration of markers of bone turnover.	P1NP and ß-CTX.	Change from baseline concentration at 6 weeks.
Secondary	Change in plasma concentration of markers of inflammation.	C-reactive protein and IL-6.	Change from baseline concentration at 6 weeks.
Secondary	Change in handgrip strength.	Assessed using a handgrip dynamometer, measured in kilograms.	Change from baseline strength at 6 weeks.
Secondary	Change in isometric knee extensor strength	Assesed using an isokinetic dynamometer, measured in Newtons.	Change from baseline strength at 6 weeks.
Secondary	Change in isokinetc knee extensor strength	Assesed using an isokinetic dynamometer, measured in Newtons.	Change from baseline strength at 6 weeks.