Clinical trial NCT05025917: Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women
Official title: Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women: A Randomised Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Osteoporosis, Postmenopausal
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.
timeFrame: Change from baseline myogenin expression at 6 weeks.
Secondary outcomes:
measure: Change in plasma concentration of markers of bone turnover.
timeFrame: Change from baseline concentration at 6 weeks.
measure: Change in plasma concentration of markers of inflammation.
timeFrame: Change from baseline concentration at 6 weeks.
measure: Change in handgrip strength.
timeFrame: Change from baseline strength at 6 weeks.
measure: Change in isometric knee extensor strength
timeFrame: Change from baseline strength at 6 weeks.
measure: Change in isokinetc knee extensor strength
timeFrame: Change from baseline strength at 6 weeks.
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Deparment of Sport and Health Sciences
state: Devon
Study officials:
affiliation: University of Exeter
name: Mary O'Leary
role: PRINCIPAL_INVESTIGATOR
References: