RecruitingNot ApplicableNCT07135232

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

The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial


Sponsor

Leeds Beckett University

Enrollment

72 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a plant-based supplement combined with a resistance training exercise program helps perimenopausal women maintain muscle mass, improve strength, and manage body composition changes during the menopause transition. **You may be eligible if...** - You are a woman between 40 and 55 years old going through perimenopause - You are not currently doing regular structured resistance exercise (less than 3 sessions per week for the past 6 months) - You have not been on hormone replacement therapy (HRT) or hormonal birth control for at least 1 year - You can attend lab visits and commit to a 6-month program - You are willing to provide blood samples **You may NOT be eligible if...** - You are currently using HRT or hormonal contraception - You are already taking dietary supplements containing sarmentosin or L-theanine (compounds in the study supplement) - You regularly eat large amounts of blackcurrants - You are not in perimenopause (either pre- or post-menopausal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSarmentosin - L- theanine

Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine

OTHERResistance Training

Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.

DIETARY_SUPPLEMENTPlacebo Supplement

Capsules matched for taste and appearance, without any active ingredients.


Locations(1)

Carnegie School of Sport

Leeds, North Humberside, United Kingdom

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NCT07135232


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