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

NCT05025917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-08-30

No results posted yet for this study

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.

Conditions

  • Muscle Weakness
  • Osteoporosis, Postmenopausal

Interventions

DIETARY_SUPPLEMENT

Shatavari

Shatavari root powder

DIETARY_SUPPLEMENT

Magnesium stearate

Magnesium stearate powder

Sponsors & Collaborators

  • University of Exeter

    lead OTHER

Principal Investigators

  • Mary O'Leary · University of Exeter

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2020-01-17
Completion
2020-01-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05025917 on ClinicalTrials.gov