NCT05025917

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

Completed NA Last updated 30 August 2021

What this trial tests

NA trial testing Shatavari in Muscle Weakness in 24 participants. Completed in 17 January 2020.

Timeline

16 April 2019

Primary endpoint
17 January 2020

17 January 2020

Quick facts

Lead sponsor	University of Exeter
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	24
Start date	16 April 2019
Primary completion	17 January 2020
Estimated completion	17 January 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Shatavari
• Magnesium stearate — full drug profile →

Conditions studied

• Muscle Weakness — all drugs for Muscle Weakness →
• Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →

Sponsor

University of Exeter

Who can join

60 and older, female only, with Muscle Weakness or Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation.
   O'Leary MF, Jackman SR, Bowtell JL. · · 2024 · cited 8× · PMID 38214710 · DOI 10.1007/s00394-023-03310-w
2. Shatavari Supplementation in Postmenopausal Women Alters the Skeletal Muscle Proteome and Pathways Involved in Training Adaptation
   O'Leary M, Jackman SR, Bowtell JL. · · 2023 · DOI 10.21203/rs.3.rs-2369451/v2
3. Shatavari Supplementation in Postmenopausal Women Improves Handgrip Strength and Increases <i>Vastus Lateralis</i> Myosin Regulatory Light Chain Phosphorylation But Does Not Alter Markers of Bone Turnover: A Randomised Controlled Trial
   O’Leary MF, Jackman SR, Sabou VR, Campbell MI, et al · · 2021 · DOI 10.1101/2021.09.16.21263687