Status:
NOT_YET_RECRUITING
The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
Lead Sponsor:
Leeds Beckett University
Conditions:
Perimenopause
Menopause
Eligibility:
FEMALE
40-55 years
Phase:
NA
Brief Summary
The aim of this clinical trial is to determine if resistance training and a newly developed plant-based nutritional supplement can improve the symptoms and musculoskeletal health of perimenopausal wom...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Perimenopausal women between 40 - 55 years
- Not currently engaging in consistent structured resistance training (defined as \>3 resistance training sessions per week for 4 consecutive weeks, in the past six months).
- Not on any HRT or hormonal contraception for at least one year before initiation of the study.
- Able to attend laboratory visits and commit to the intervention schedule for 6 months.
- Willing to provide blood samples
- Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention.
- Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea).
- Willing and able to provide written informed consent
- Exclusion criteria
- Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation.
- Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months).
- Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy).
- Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction).
- History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months
- Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
- Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5)
- Food allergy or intolerance to study products.
- Use of illicit drugs.
- Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks).
- Pregnant or planning to conceive during the trial.
- High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07135232
Start Date
January 1 2026
End Date
December 15 2026
Last Update
January 6 2026
Active Locations (1)
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1
Carnegie School of Sport
Leeds, North Humberside, United Kingdom, LS2 3AE