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

What this trial studies

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.

Conditions in scope

• Perimenopause
• Menopause

Interventions

• Sarmentosin - L- theanine (Dietary 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. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
• Placebo Supplement (Dietary Supplement) — Capsules matched for taste and appearance, without any active ingredients.

Who can join

Women only · Ages 40 Years to 55 Years · Accepts healthy volunteers.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Last update posted: 2026-03-27
• First posted: 2025-08-22

Sponsor & contact

Lead sponsor: Leeds Beckett University (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Depressive Symptom Score at week 4 (Week 4)
  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.
• Depressive Symptom Score at Week 8 (Week 8)
  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.
• Depressive Symptom Score at Week 12 (Week 12)
  Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Assessed on a scale from 0 - 3 over 7 questions, with a maximum score of 42. Higher scores indicate more severe depressive symptoms.
• Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1 (Pre- to 1 hour post- supplement intake at week 1 of the intervention.)
  Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the Cambridge Neuropsychological Test Automated Battery rapid visual information processing test.
• Change in Sustained Attention Pre- to Post-Supplement Intake at Week 12 (Pre- to 1 hour post- supplement intake at week 12 of the intervention.)
  Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the Cambridge Neuropsychological Test Automated Battery rapid visual information processing test.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.