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Completed

NCT Number: NCT05025917

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shatavari

Dietary Supplement

Shatavari root powder

Other names: Asparagus Racemosus

Magnesium stearate

Dietary Supplement

Magnesium stearate powder

Primary outcomes

  1. Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.

    Time frame: Change from baseline myogenin expression at 6 weeks.

    Measured via immunoblotting.

Secondary outcomes

  1. Change in plasma concentration of markers of bone turnover.

    Time frame: Change from baseline concentration at 6 weeks.

    P1NP and β-CTX.

  2. Change in plasma concentration of markers of inflammation.

    Time frame: Change from baseline concentration at 6 weeks.

    C-reactive protein and IL-6.

  3. Change in handgrip strength.

    Time frame: Change from baseline strength at 6 weeks.

    Assessed using a handgrip dynamometer, measured in kilograms.

  4. Change in isometric knee extensor strength

    Time frame: Change from baseline strength at 6 weeks.

    Assesed using an isokinetic dynamometer, measured in Newtons.

  5. Change in isokinetc knee extensor strength

    Time frame: Change from baseline strength at 6 weeks.

    Assesed using an isokinetic dynamometer, measured in Newtons.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2021
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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