PerimenopauseNCT07135232
The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
A study testing Sarmentosin - L- theanine and Resistance Training in people with Perimenopause and Menopause, run by Leeds Beckett University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause, Menopause
- What is being tested?
- Sarmentosin - L- theanine and Resistance Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- Obesity (BMI >30 or for South Asian Ethinicity BMI> 27.5)
- Food allergy or intolerance to study products.
- Use of illicit drugs.
- Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks).
- Pregnant or planning to conceive during the trial.
- High habitual caffeine intake (>400 mg/day which is approximately 4-5 cups of coffee)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Theocharis Ispogolou contact
United Kingdom1 site, 1 recruiting
- Recruiting
Carnegie School of Sport
Leeds, North Humberside, LS2 3AE
Harriet Cannell, +44 7805576688, H.cannell@leedsbeckett.ac.uk
Theocharis Ispoglou, T.Ispoglou@leedsbeckett.ac.uk
About this study
Official title: The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled 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:
Read more
- 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)?
- 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)?
- 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:
- The nutritional supplement + resistance training
- The nutritional supplement only
- The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training
- 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.
- Conditions
- Perimenopause, Menopause
- Being tested
- Sarmentosin - L- theanine, Resistance Training, Placebo Supplement
- Keywords
- Mood, Depression, Cognition, Resistance Training, Sarmentosin - L-theanine, Bioactive supplement, perimenopause symptoms, menopause, lifestyle, muscle, health, exercise, perimenopause, symptoms, hot flashes, vasomotor, anxiety, stress
- Medical subject headings
- Depression, Motor Activity, Hot Flashes, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarmentosin - L- theanineDietary supplement
Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
Resistance TrainingOther
Also called Strength Training, Resistance Exercise, Strength Exercise
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Placebo SupplementDietary supplement
Capsules matched for taste and appearance, without any active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Supplement Only | Placebo comparator | Two placebo capsules to be consumed by participants daily Receives: Dietary Supplement: Placebo Supplement |
| Placebo Supplement and Resistance Training | Experimental | Participants will consume two placebo supplements daily, and perform structured resistance training three times per week. Receives: Other: Resistance Training; Dietary Supplement: Placebo Supplement |
| Active Supplement Only | Experimental | Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily. Receives: Dietary Supplement: Sarmentosin - L- theanine |
| Active Supplement and Resistance Training | Experimental | Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week. Receives: Dietary Supplement: Sarmentosin - L- theanine; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre- to 1 hour post- supplement intake at week 12 of the intervention.
Secondary outcomes (51)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Change in Handgrip Strength from baseline to Week 12
Assessed using a handgrip dynamometer.
Measured: Baseline and Week 12
change in Leg Extensor Submaximal Strength from baseline to Week 12
Assessed using the 4-6RM leg extensor strength test.
Measured: 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
Measured: 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
Measured: baseline and Week 12
Change in Appendicular Lean Mass from baseline to Week 12
Measured using dual X-ray Absorptiometry
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harriet Cannell, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135232
- Sponsor's protocol ID
- AM004156
- Status last verified
- Mar 2026
- First submitted
- 14 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07135232
- Acronym / sponsor ID
- AM004156
- Conditions
- Perimenopause, Menopause
- Keywords
- Mood, Depression, Cognition, Resistance Training, Sarmentosin - L-theanine, Bioactive supplement, perimenopause symptoms, menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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)?
- 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:
- The nutritional supplement + resistance training
- The nutritional supplement only
- The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Supplement Only | Placebo comparator | Dietary Supplement: Placebo SupplementTwo placebo capsules to be consumed by participants daily |
| Placebo Supplement and Resistance Training | Experimental | Other: Resistance Training, Dietary Supplement: Placebo SupplementParticipants will consume two placebo supplements daily, and perform structured resistance training three times per week. |
| Active Supplement Only | Experimental | Dietary Supplement: Sarmentosin - L- theanineParticipants will consume two capsules of the Sarmentosin - L-theanine supplement daily. |
| Active Supplement and Resistance Training | Experimental | Dietary Supplement: Sarmentosin - L- theanine, Other: Resistance TrainingParticipants will consume two capsules of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarmentosin - L- theanineTwo capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine | Dietary supplement | Active Supplement Only, Active Supplement and Resistance Training |
| Resistance TrainingAlso: Strength Training, Resistance Exercise, Strength ExerciseHome-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles. | Other | Active Supplement and Resistance Training, Placebo Supplement and Resistance Training |
| Placebo SupplementCapsules matched for taste and appearance, without any active ingredients. | Dietary supplement | Placebo Supplement Only, Placebo Supplement and Resistance Training |
Primary outcome
Depressive Symptom Score at week 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
51 secondary outcomes
Verbal Episodic Memory Performance at Week 4
Time frame: Week 4
Verbal Episodic Memory Performance at Week 8
Time frame: Week 8
Verbal Episodic Memory Performance at Week 12
Time frame: Week 12
Working Memory Performance at Week 4
Time frame: Week 4
Working Memory Performance at Week 8
Time frame: Week 8
Working Memory Performance at Week 12
Time frame: Week 12
Spatial Planning and Working Memory Performance at Week 4
Time frame: Week 4
Spatial Planning and Working Memory Performance at week 8
Time frame: Week 8
Spatial Planning and Working Memory Performance at Week 12
Time frame: Week 12
Sustained Attention Performance at Week 4
Time frame: Week 4
Sustained Attention Performance at week 8
Time frame: Week 8
Sustained Attention Performance at Week 12
Time frame: Week 12
Subjective Memory Complaints at Week 4
Time frame: Week 4
Subjective Memory Complaints at Week 8
Time frame: Week 8
Subjective Memory Complaints at Week 12
Time frame: Week 12
Self-reported Sleep Quality at Week 4
Time frame: Week 4
Self-reported Sleep Quality at Week 8
Time frame: Week 8
Self-reported Sleep Quality at Week 12
Time frame: Week 12
Self-reported Hot Flash Severity and Frequency at Week 4
Time frame: Week 4
Self-reported Hot Flash Severity and Frequency at Week 8
Time frame: Week 8
Self-reported Hot Flash Severity and Frequency at Week 12
Time frame: Week 12
Anxiety Symptoms at Week 4
Time frame: Week 4
Anxiety Symptoms at Week 8
Time frame: Week 8
Anxiety Symptoms at Week 12
Time frame: Week 12
Stress symptoms at Week 4
Time frame: Week 4
Stress Symptoms at Week 8
Time frame: Week 8
Stress Symptoms at Week 12
Time frame: Week 12
Quality of Life Score at Week 4
Time frame: Week 4
Quality of Life Score at Week 8
Time frame: Week 8
Quality of Life Score at Week 12
Time frame: Week 12
Change in Handgrip Strength from baseline to Week 12
Time frame: Baseline and Week 12
change in Leg Extensor Submaximal Strength from baseline to Week 12
Time frame: Baseline and Week 12
Change in Isometric Mid-thigh Pull Strength from baseline to Week 12
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
Time frame: baseline and Week 12
Change in Appendicular Lean Mass from baseline to Week 12
Time frame: Baseline and Week 12
Felt-affect Visual Analogue score at week 4
Time frame: Week 4
Felt-affect Visual Analogue score at week 8
Time frame: Week 8
Felt-affect Visual Analogue score at week 12
Time frame: Week 12
Exercise Enjoyment at week 1
Time frame: Week 1
Exercise Enjoyment at week 4
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theocharis Ispogolou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sarmentosin - L- theanine and Resistance Training in people with Perimenopause and Menopause, run by Leeds Beckett University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harriet Cannell (+447805576688, H.cannell@leedsbeckett.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom Score at week 4 (time frame: Week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.