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

Primary Purpose

Muscle Weakness, Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Shatavari
Magnesium stearate
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscle Weakness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Deparment of Sport and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shatavari

Placebo

Arm Description

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.

1000 mg per day magnesium stearate powder (2 x 500 mg opaque capsules). Ingested in the morning, daily for 6 weeks.

Outcomes

Primary Outcome Measures

Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.
Measured via immunoblotting.

Secondary Outcome Measures

Change in plasma concentration of markers of bone turnover.
P1NP and β-CTX.
Change in plasma concentration of markers of inflammation.
C-reactive protein and IL-6.
Change in handgrip strength.
Assessed using a handgrip dynamometer, measured in kilograms.
Change in isometric knee extensor strength
Assesed using an isokinetic dynamometer, measured in Newtons.
Change in isokinetc knee extensor strength
Assesed using an isokinetic dynamometer, measured in Newtons.

Full Information

First Posted
August 11, 2021
Last Updated
August 24, 2021
Sponsor
University of Exeter
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1. Study Identification

Unique Protocol Identification Number
NCT05025917
Brief Title
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women
Official Title
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women: A Randomised Double Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Exeter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shatavari
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1000 mg per day magnesium stearate powder (2 x 500 mg opaque capsules). Ingested in the morning, daily for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Shatavari
Other Intervention Name(s)
Asparagus Racemosus
Intervention Description
Shatavari root powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium stearate
Intervention Description
Magnesium stearate powder
Primary Outcome Measure Information:
Title
Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.
Description
Measured via immunoblotting.
Time Frame
Change from baseline myogenin expression at 6 weeks.
Secondary Outcome Measure Information:
Title
Change in plasma concentration of markers of bone turnover.
Description
P1NP and β-CTX.
Time Frame
Change from baseline concentration at 6 weeks.
Title
Change in plasma concentration of markers of inflammation.
Description
C-reactive protein and IL-6.
Time Frame
Change from baseline concentration at 6 weeks.
Title
Change in handgrip strength.
Description
Assessed using a handgrip dynamometer, measured in kilograms.
Time Frame
Change from baseline strength at 6 weeks.
Title
Change in isometric knee extensor strength
Description
Assesed using an isokinetic dynamometer, measured in Newtons.
Time Frame
Change from baseline strength at 6 weeks.
Title
Change in isokinetc knee extensor strength
Description
Assesed using an isokinetic dynamometer, measured in Newtons.
Time Frame
Change from baseline strength at 6 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O'Leary
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deparment of Sport and Health Sciences
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX12LU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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