An interventional study of Sarmentosin - L- theanine and Resistance Training in Perimenopause and Menopause, sponsored by Leeds Beckett University. Recruiting at 1 site in United Kingdom. Open to female participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Leeds Beckett University · Not applicable, Interventional, and Supportive care
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:
Participants will be split into four groups to allow the researchers to answer the above questions. These are:
Participants will:
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 72 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Leeds Beckett University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two placebo capsules to be consumed by participants daily
Dietary Supplement: Placebo Supplement
Participants will consume two placebo supplements daily, and perform structured resistance training three times per week.
Other: Resistance Training · Dietary Supplement: Placebo Supplement
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily.
Dietary Supplement: Sarmentosin - L- theanine
Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.
Dietary Supplement: Sarmentosin - L- theanine · Other: Resistance Training
Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Also known as: Strength Training, Resistance Exercise, Strength Exercise
Capsules matched for taste and appearance, without any active ingredients.
Depressive Symptom Score at 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.
Time frame: Week 4
Depressive Symptom Score at 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.
Time frame: Week 8
Depressive Symptom Score at 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.
Time frame: Week 12
Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1
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.
Time frame: Pre- to 1 hour post- supplement intake at week 1 of the intervention.
Change in Sustained Attention Pre- to Post-Supplement Intake at Week 12
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.
Time frame: Pre- to 1 hour post- supplement intake at week 12 of the intervention.
Verbal Episodic Memory Performance at Week 4
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.
Time frame: Week 4
Verbal Episodic Memory Performance at Week 8
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task
Time frame: Week 8
Verbal Episodic Memory Performance at Week 12
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.
Time frame: Week 12
Working Memory Performance at Week 4
Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task.
Time frame: Week 4
Working Memory Performance at Week 8
Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task
Time frame: Week 8
Working Memory Performance at Week 12
Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task.
Time frame: Week 12
Spatial Planning and Working Memory Performance at Week 4
Assessed as the total number of assessed trials where the subject chose the correct answer on their first attempt in the One touch stockings of Cambridge task.
Time frame: Week 4
Spatial Planning and Working Memory Performance at week 8
Assessed as the total number of assessed trials where the subject chose the correct answer on their first attempt in the One touch stockings of Cambridge task.
Time frame: Week 8
Spatial Planning and Working Memory Performance at Week 12
Assessed as the total number of assessed trials where the subject chose the correct answer on their first attempt in the One touch stockings of Cambridge task.
Time frame: Week 12
Sustained Attention Performance at Week 4
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.
Time frame: Week 4
Sustained Attention Performance at week 8
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
Time frame: Week 8
Sustained Attention Performance at Week 12
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.
Time frame: Week 12
Subjective Memory Complaints at Week 4
Assessed using the Everyday Memory Questionnaire - Revised. Retrieval subscale (seven items, range 0-28) and the attentional subscale (four items, score range 0-16). A higher score indicates greater presence of subjective memory or attention difficulties.
Time frame: Week 4
Subjective Memory Complaints at Week 8
Assessed using the Everyday Memory Questionnaire - Revised. Retrieval subscale (seven items, range 0-28) and the attentional subscale (four items, score range 0-16). A higher score indicates greater presence of subjective memory or attention difficulties.
Time frame: Week 8
Subjective Memory Complaints at Week 12
Assessed using the Everyday Memory Questionnaire - Revised. Retrieval subscale (seven items, range 0-28) and the attentional subscale (four items, score range 0-16). A higher score indicates greater presence of subjective memory or attention difficulties.
Time frame: Week 12
Self-reported Sleep Quality at Week 4
Assessed using the Pittsburgh sleep quality index. Each component is scored from 0 to 3, to give a global score between 0 and 21.Higher scores signify poorer subjective sleep quality.
Time frame: Week 4
Self-reported Sleep Quality at Week 8
Assessed using the Pittsburgh sleep quality index. Each component is scored from 0 to 3, to give a global score between 0 and 21. Higher scores signify poorer subjective sleep quality.
Time frame: Week 8
Self-reported Sleep Quality at Week 12
Assessed using the Pittsburgh sleep quality index. Each component is scored from 0 to 3, to give a global score between 0 and 21. Higher scores signify poorer subjective sleep quality.
Time frame: Week 12
Self-reported Hot Flash Severity and Frequency at Week 4
Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating. Scored on a scale from 1 -10, the overall problem rating is calculated as the mean from the three items. A higher score indicates greater problem rating.
Time frame: Week 4
Self-reported Hot Flash Severity and Frequency at Week 8
Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating. Scored on a scale from 1 -10, the overall problem rating is calculated as the mean from the three items. A higher score indicates greater problem rating.
Time frame: Week 8
Self-reported Hot Flash Severity and Frequency at Week 12
Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating. Scored on a scale from 1 -10, the overall problem rating is calculated as the mean from the three items. A higher score indicates greater problem rating.
Time frame: Week 12
Anxiety Symptoms at Week 4
Assessed using the anxiety 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 anxiety symptoms.
Time frame: Week 4
Anxiety Symptoms at Week 8
Assessed using the anxiety 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 anxiety symptoms.
Time frame: Week 8
Anxiety Symptoms at Week 12
Assessed using the anxiety 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 anxiety symptoms.
Time frame: Week 12
Stress symptoms at Week 4
Assessed using the stress 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 stress symptoms.
Time frame: Week 4
Stress Symptoms at Week 8
Assessed using the stress 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 stress symptoms.
Time frame: Week 8
Stress Symptoms at Week 12
Assessed using the stress 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 stress symptoms.
Time frame: Week 12
Quality of Life Score at Week 4
Assessed using the menopause specific quality of life questionnaire. The score for each domain ranges from 1 to 8, and the overall problem rating is calculated as the mean score. Higher score represents worse quality of life.
Time frame: Week 4
Quality of Life Score at Week 8
Assessed using the menopause specific quality of life questionnaire. The score for each domain ranges from 1 to 8, and the overall problem rating is calculated as the mean score. Higher score represents worse quality of life.
Time frame: Week 8
Quality of Life Score at Week 12
Assessed using the menopause specific quality of life questionnaire. The score for each domain ranges from 1 to 8, and the overall problem rating is calculated as the mean score. Higher score represents worse quality of life.
Time frame: Week 12
Change in Handgrip Strength from baseline to Week 12
Assessed using a handgrip dynamometer.
Time frame: Baseline and Week 12
change in Leg Extensor Submaximal Strength from baseline to Week 12
Assessed using the 4-6RM leg extensor strength test.
Time frame: Baseline and Week 12
Change in Isometric Mid-thigh Pull Strength from baseline to Week 12
Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration
Time frame: Baseline and Week 12
Change in the Number of Reps Completed in the 30 Second Sit-to-stand Test from baseline to week 12
Assessed as the number of reps completed in 30 seconds
Time frame: baseline and Week 12
Change in Appendicular Lean Mass from baseline to Week 12
Measured using dual X-ray Absorptiometry
Time frame: Baseline and Week 12
Felt-affect Visual Analogue score at week 4
To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact
Time frame: Week 4
Felt-affect Visual Analogue score at week 8
To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact
Time frame: Week 8
Felt-affect Visual Analogue score at week 12
To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact
Time frame: Week 12
Exercise Enjoyment at week 1
Assessed as overall score on the physical activity enjoyment scale on a likert scale from 1 to 7. Overall score is calculated as a sum of all scores once reverse items have been calculated. Higher scores indicate greater exercise enjoyment.
Time frame: Week 1
Exercise Enjoyment at week 4
Assessed as overall score on the physical activity enjoyment scale on a likert scale from 1 to 7. Overall score is calculated as a sum of all scores once reverse items have been calculated. Higher scores indicate greater exercise enjoyment.
Time frame: Week 4
Exercise Enjoyment at week 8
Assessed as overall score on the physical activity enjoyment scale on a likert scale from 1 to 7. Overall score is calculated as a sum of all scores once reverse items have been calculated. Higher scores indicate greater exercise enjoyment.
Time frame: Week 8
Exercise Enjoyment at week 12
Assessed as overall score on the physical activity enjoyment scale on a likert scale from 1 to 7. Overall score is calculated as a sum of all scores once reverse items have been calculated. Higher scores indicate greater exercise enjoyment.
Time frame: Week 12
Change in Verbal Episodic Memory Performance from Pre- to Post-Supplement Intake in Week 1.
Measured as the number of errors during the Cambridge Neuropsychological Test Automated Battery verbal Paired associates task.
Time frame: Pre- to 1 hour post- supplement intake in week 1
Change in Verbal Episodic Memory Performance From Pre- to Post-Supplement Intake in Week 12
Measured as the number of errors during the Cambridge Neuropsychological Test Automated Battery verbal Paired associates task.
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in Working Memory Performance From Pre- to Post-Supplement Intake in Week 1
Measured as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery backwards digit span task.
Time frame: Pre- to 1 hour post- supplement intake in week 1
Change In Working Memory Performance From Pre- to Post-Supplement Intake in Week 12.
Measured as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery backwards digit span task.
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.
Measured as the number of problems completed using the minimum number of moves during the Cambridge Neuropsychological Test Automated Battery stockings of Cambridge task.
Time frame: Pre- to 1 hour post- supplement intake in week 1.
Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.
Measured as the number of problems completed using the minimum number of moves during the Cambridge Neuropsychological Test Automated Battery stockings of Cambridge task.
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in Mood State From Pre- to Post- Supplement Intake in week 1
Assessed using the Bond-Lader visual analogue scale. Scores can be split into alertness, contentment and calmness with lower scores indicating a higher experience of the positive mood state.
Time frame: Pre- to 1 hour post- supplement intake in week 1.
Change in Mood State From Pre- to Post- Supplement Intake in Week 12
Assessed using the Bond-Lader visual analogue scale. Scores can be split into alertness, contentment and calmness with lower scores indicating a higher experience of the positive mood state.
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in total body fat percentage from baseline to Week 12
Measured using dual X-ray Absorptiometry
Time frame: Baseline and Week 12
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4
Analysed using LCMS from a serum sample.
Time frame: Week 4
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8
Analysed using LCMS from a serum sample.
Time frame: Week 8
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 12
Analysed using LCMS from a serum sample.
Time frame: Week 12
Brain Derived Neurotrophic Factor at week 4
Analysed using ELISA from obtained serum sample
Time frame: Week 4
Brain Derived Neurotrophic Factor at Week 8
Analysed using ELISA from obtained serum sample
Time frame: Week 8
Brain Derived Neurotrophic Factor at Week 12
Analysed using ELISA from obtained serum sample
Time frame: Week 12
Change From Baseline in Monoamine Oxidase A & B Activity at Week 4
Analysed using Amplex assay kit.
Time frame: Baseline to Week 4
Change from baseline in Monoamine oxidase A & B activity at week 8
Analysed using Amplex assay kit.
Time frame: Baseline to week 8
Change from baseline in Monoamine oxidase A & B activity at week 12
Analysed using Amplex assay kit.
Time frame: Baseline to week 12
Change from baseline in plasma sarmentosin at week 4
Analysed using LCMS
Time frame: Baseline to week 4
Change from baseline in plasma sarmentosin at week 8
Analysed using LCMS
Time frame: Baseline to week 8
Change from baseline in plasma sarmentosin at week 12
Analysed using LCMS
Time frame: Baseline to week 12
Inflammatory Cytokines (IL6, TNF-α) at week 4
Analysed using ELISA
Time frame: Week 4
Inflammatory cytokines (e.g. IL6, TNF-α) at week 8
Analysed using ELISA
Time frame: Week 8
Inflammatory cytokines (e.g. IL6, TNF-α) at week 12
Analysed using ELISA
Time frame: Week 12
Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 1.
Analysed using LCMS
Time frame: Pre- to 1 hour post- supplement intake in week 1
Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 12
Analysed using LCMS
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 1.
Analysed using LCMS
Time frame: Pre- to 1 hour post- supplement intake in week 1
Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 12
Analysed using LCMS
Time frame: Pre- to 1 hour post- supplement intake in week 12
Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 1
Analysed using amplex assay kits
Time frame: Pre- to 1 hour post- supplement intake in week 1
Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 12
Analysed using amplex assay kits
Time frame: Pre- to 1 hour post- supplement intake in week 12
Plan to share: Undecided
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Leeds Beckett University