Muscle WeaknessNCT05025917
Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women
A study testing Shatavari and Magnesium stearate in people with Muscle Weakness and Osteoporosis, Postmenopausal, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Osteoporosis, Postmenopausal
- What is being tested?
- Shatavari and Magnesium stearate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2019to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (Last menstrual period > 12 months ago)
- Aged 60 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Deparment of Sport and Health Sciences
Exeter, Devon, EX12LU
About this study
Official title: 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.
- Conditions
- Muscle Weakness, Osteoporosis, Postmenopausal
- Being tested
- Shatavari, Magnesium stearate
- Medical subject headings
- Muscle Weakness, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShatavariDietary supplement
Also called Asparagus Racemosus
Shatavari root powder
Magnesium stearateDietary supplement
Magnesium stearate powder
| Study group | Role | What they receive |
|---|---|---|
| Shatavari | Experimental | 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. Receives: Dietary Supplement: Shatavari |
| Placebo | Placebo comparator | 1000 mg per day magnesium stearate powder (2 x 500 mg opaque capsules). Ingested in the morning, daily for 6 weeks. Receives: Dietary Supplement: Magnesium stearate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in protein expression of myogenin in vastus lateralis skeletal muscle samples.
Measured via immunoblotting.
Measured: Change from baseline myogenin expression at 6 weeks.
Secondary outcomes (5)
Change in plasma concentration of markers of bone turnover.
P1NP and β-CTX.
Measured: Change from baseline concentration at 6 weeks.
Change in plasma concentration of markers of inflammation.
C-reactive protein and IL-6.
Measured: Change from baseline concentration at 6 weeks.
Change in handgrip strength.
Assessed using a handgrip dynamometer, measured in kilograms.
Measured: Change from baseline strength at 6 weeks.
Change in isometric knee extensor strength
Assesed using an isokinetic dynamometer, measured in Newtons.
Measured: Change from baseline strength at 6 weeks.
Change in isokinetc knee extensor strength
Assesed using an isokinetic dynamometer, measured in Newtons.
Measured: Change from baseline strength at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start16 Apr 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary O'Leary, University of Exeter
- Investigators
- Mary O'Leary, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025917
- Sponsor's protocol ID
- 190206/B/01
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
O'Leary MF, Jackman SR, Bowtell JL. Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation. Eur J Nutr. 2024 Apr;63(3):869-879. doi: 10.1007/s00394-023-03310-w. Epub 2024 Jan 12.
PubMed 38214710
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women: A Randomised Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05025917
- Acronym / sponsor ID
- 190206/B/01
- Conditions
- Muscle Weakness, Osteoporosis, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shatavari | Experimental | Dietary Supplement: Shatavari1000 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. |
| Placebo | Placebo comparator | Dietary Supplement: Magnesium stearate1000 mg per day magnesium stearate powder (2 x 500 mg opaque capsules). Ingested in the morning, daily for 6 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women (Last menstrual period > 12 months ago)
- Aged 60 years or older
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShatavariAlso: Asparagus RacemosusShatavari root powder | Dietary supplement | Shatavari |
| Magnesium stearateMagnesium stearate powder | Dietary supplement | Placebo |
Primary outcome
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.
5 secondary outcomes
Change in plasma concentration of markers of bone turnover.
Time frame: Change from baseline concentration at 6 weeks.
Change in plasma concentration of markers of inflammation.
Time frame: Change from baseline concentration at 6 weeks.
Change in handgrip strength.
Time frame: Change from baseline strength at 6 weeks.
Change in isometric knee extensor strength
Time frame: Change from baseline strength at 6 weeks.
Change in isokinetc knee extensor strength
Time frame: Change from baseline strength at 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 38214710O'Leary MF, Jackman SR, Bowtell JL. Shatavari supplementation in postmenopausal women alters the skeletal muscle proteome and pathways involved in training adaptation. Eur J Nutr. 2024 Apr;63(3):869-879. doi: 10.1007/s00394-023-03310-w. Epub 2024 Jan 12.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary O'Leary principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shatavari and Magnesium stearate in people with Muscle Weakness and Osteoporosis, Postmenopausal, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in protein expression of myogenin in vastus lateralis skeletal muscle samples. (time frame: Change from baseline myogenin expression at 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.