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The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.

Sponsor: Leeds Beckett University

NCT ID: NCT07135232

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sarmentosin - L- theanine (supplement), Resistance Training (other), Placebo Supplement (supplement)
How long the study runs
Study runs about 13 months (dates as stated)
About the drug or intervention
Sarmentosin - L- theanine — supplement: Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine · Resistance Training — other: Home-based Resistance training. · Placebo Supplement — supplement: Capsules matched for taste and appearance, without any active ingredients.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 55 Years
Who
Female
Number of participants
72
Started
2026-03-01
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for perimenopause
  • • NA - 72 participants
  • • 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 women

Who can take part?

  • • Ages 40 Years to 55 Years
  • • Diagnosed with perimenopause
  • • Female only

Where?

  • • Leeds - Carnegie School of Sport

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 women. The main questions it aims to evaluate are: 1. Can resistance training and the nutritional supplement - both independently and in combination - improve perimenopausal symptoms (e.g. cognition, mood, sleep) and musculoskeletal outcomes (e.g. strength, muscle mass)? 2. What are the acute effects of the nutritional supplement on cognitive function and mood in perimenopausal women, and is this response altered following long-term intake (12 weeks)? 3. What mechanisms may be contributing to the results? Participants will be split into four groups to allow the researchers to answer the above questions. These are: 1. The nutritional supplement + resistance training 2. The nutritional supplement only 3. The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training 4. The Placebo supplement only. Participants will: * Take their allocated supplement daily and perform home-based strength exercise 3 times per week (for exercise groups), for 12 weeks. * Attend the laboratory at the beginning and end of the 12 weeks to assess cognitive function and mood following acute intake of the supplement. * Attend the laboratory every 4 weeks during the 12 week period, for assessment of cognitive function, symptom severity and muscle health. * Provide a blood sample at each visit for assessment of mechanistic pathways.

PerimenopauseMenopause

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 55 Years
  • Who can join: Female only

What the study is looking for

  • ✓Inclusion criteria
  • ✓Perimenopausal women between 40 - 55 years
  • ✓Not currently engaging in consistent structured resistance training (defined as \>3 resistance training sessions per...
  • ✓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.
See the full criteria
Inclusion criteria 1. Perimenopausal women between 40 - 55 years 2. 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). 3. Not on any HRT or hormonal contraception for at least one year before initiation of the study. 4. Able to attend laboratory visits and commit to the intervention schedule for 6 months. 5. Willing to provide blood samples 6. Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention. 7. Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea). 8. Willing and able to provide written informed consent Exclusion criteria 1. Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation. 2. Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months). 3. Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy). 4. Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction). 5. History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months 6. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers. 7. Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5) 8. Food allergy or intolerance to study products. 9. Use of illicit drugs. 10. Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks). 11. Pregnant or planning to conceive during the trial. 12. High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)

Where Is This Study? (1 UK site)

Carnegie School of Sport

Leeds LS2 3AE, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Harriet Cannell

Sponsor contact

CONTACT

+447805576688 H.cannell@leedsbeckett.ac.uk

Theocharis Ispogolou

Sponsor contact

CONTACT

T.Ispoglou@leedsbeckett.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03