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

Study Overview
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Brief Summary
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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.

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

Conditions
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Muscle Weakness, Osteoporosis, Postmenopausal

Intervention / Treatment
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* Dietary Supplement: Shatavari
* Dietary Supplement: Magnesium stearate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shatavari<br>1000 mg per day shatavari root powder (2 x 500 mg opaque capsules; equivalent to 26,500 mg fresh weight shatavari). Ingested in the morning, daily for 6 weeks. | Dietary Supplement: Shatavari<br>* Shatavari root powder<br>* Other names: Asparagus Racemosus;|
| Placebo Comparator: Placebo<br>1000 mg per day magnesium stearate powder (2 x 500 mg opaque capsules). Ingested in the morning, daily for 6 weeks. | Dietary Supplement: Magnesium stearate<br>* Magnesium stearate powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in protein expression of myogenin in vastus lateralis skeletal muscle samples. | Measured via immunoblotting. | Change from baseline myogenin expression at 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma concentration of markers of bone turnover. | P1NP and β-CTX. | Change from baseline concentration at 6 weeks. | 
| Change in plasma concentration of markers of inflammation. | C-reactive protein and IL-6. | Change from baseline concentration at 6 weeks. | 
| Change in handgrip strength. | Assessed using a handgrip dynamometer, measured in kilograms. | Change from baseline strength at 6 weeks. | 
| Change in isometric knee extensor strength | Assesed using an isokinetic dynamometer, measured in Newtons. | Change from baseline strength at 6 weeks. | 
| Change in isokinetc knee extensor strength | Assesed using an isokinetic dynamometer, measured in Newtons. | Change from baseline strength at 6 weeks. |