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

NCT05025917 | Completed

• 1 other identifier: 190206/B/01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

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

  Measured via immunoblotting.

  Change from baseline myogenin expression at 6 weeks.

Secondary Outcomes (5)

• Change in plasma concentration of markers of bone turnover.

  Change from baseline concentration at 6 weeks.

• Change in plasma concentration of markers of inflammation.

  Change from baseline concentration at 6 weeks.

• Change in handgrip strength.

  Change from baseline strength at 6 weeks.

• Change in isometric knee extensor strength

  Change from baseline strength at 6 weeks.

• Change in isokinetc knee extensor strength

  Change from baseline strength at 6 weeks.

Study Arms (2)

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.

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.

Dietary Supplement: Magnesium stearate

Interventions

Shatavari DIETARY_SUPPLEMENT

Shatavari root powder

Also known as: Asparagus Racemosus

Shatavari

Magnesium stearate DIETARY_SUPPLEMENT

Magnesium stearate powder

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (Last menstrual period \> 12 months ago)
• Aged 60 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

Deparment of Sport and Health Sciences

Exeter, Devon, EX12LU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38214710 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Osteoporosis, Postmenopausal

Interventions

stearic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mary O'Leary

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 30, 2021
• Study Start: April 16, 2019
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)