Muscle Weakness, Osteoporosis, Postmenopausal
Conditions
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.
Interventions
DIETARY_SUPPLEMENTShatavari
Shatavari root powder
DIETARY_SUPPLEMENTMagnesium stearate
Magnesium stearate powder
Sponsors
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in protein expression of myogenin in vastus lateralis skeletal muscle samples. | Change from baseline myogenin expression at 6 weeks. | Measured via immunoblotting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma concentration of markers of bone turnover. | Change from baseline concentration at 6 weeks. | P1NP and β-CTX. |
| Change in plasma concentration of markers of inflammation. | Change from baseline concentration at 6 weeks. | C-reactive protein and IL-6. |
| Change in handgrip strength. | Change from baseline strength at 6 weeks. | Assessed using a handgrip dynamometer, measured in kilograms. |
| Change in isometric knee extensor strength | Change from baseline strength at 6 weeks. | Assesed using an isokinetic dynamometer, measured in Newtons. |
| Change in isokinetc knee extensor strength | Change from baseline strength at 6 weeks. | Assesed using an isokinetic dynamometer, measured in Newtons. |
Countries
United Kingdom
Outcome results
None listed