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

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Osteoporosis, Postmenopausal
• Intervention / Treatment: Dietary supplement: Shatavari; Dietary supplement: Magnesium stearate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX12LU
      • Deparment of Sport and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shatavari; 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; Shatavari root powder; Other Names: Asparagus Racemosus
Placebo Comparator: Placebo; 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; Magnesium stearate powder

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Exeter
• Investigators: Principal Investigator: Mary O'Leary, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Bone Diseases; Bone Diseases, Metabolic; Muscle Weakness; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: 190206/B/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There are no plans to make IPD available. However, deidentified IPD may be made available to other researchers, on reasonable request to the Principal Investigator, provided this can be done in compliance with General Data Protection Regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No