Resistance training with a plant-based supplement for perimenopausal symptoms and muscle health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Perimenopausal women are randomized into four groups to receive a plant-based supplement (sarmentosin + L-theanine), a placebo, supervised resistance training, or combinations of these interventions. The study measures symptoms such as mood, cognition, and sleep alongside musculoskeletal outcomes including strength and muscle mass. Researchers will examine both acute effects of the supplement on cognition and mood and longer-term responses after weeks of intake, while collecting blood samples to explore possible biological mechanisms. Participants are expected to attend laboratory visits over the intervention period and follow dietary restrictions regarding sources of sarmentosin and L-theanine.

Why it matters

Who can join: the full rules

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 it's running

• Carnegie School of Sport
  Leeds, North Humberside, United Kingdom Recruiting

Study contacts

• Study coordinator: Harriet Cannell
• Email: H.cannell@leedsbeckett.ac.uk
• Phone: +447805576688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.