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NCT Number: NCT07135232

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

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.

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Key information

Conditions

Perimenopause Anxiety Disorders Behavior Behavioral Symptoms Depression Hot Flashes Menopause Mental Disorders Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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)

Treatment and study plan

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.

Other names: Strength Training, Resistance Exercise, Strength Exercise

Placebo supplement

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Verbal Episodic Memory Performance at Week 4

    Time frame: Week 4

    Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.

  2. Verbal Episodic Memory Performance at Week 8

    Time frame: Week 8

    Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task

  3. Verbal Episodic Memory Performance at Week 12

    Time frame: Week 12

    Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.

  4. Working Memory Performance at Week 4

    Time frame: Week 4

    Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task.

  5. Working Memory Performance at Week 8

    Time frame: Week 8

    Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task

  6. Working Memory Performance at Week 12

    Time frame: Week 12

    Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task.

  7. Spatial Planning and Working Memory Performance at Week 4

    Time frame: 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.

  8. Spatial Planning and Working Memory Performance at week 8

    Time frame: 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.

  9. Spatial Planning and Working Memory Performance at Week 12

    Time frame: 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.

  10. Sustained Attention Performance at Week 4

    Time frame: 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.

  11. Sustained Attention Performance at week 8

    Time frame: 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

  12. Sustained Attention Performance at Week 12

    Time frame: 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.

  13. Subjective Memory Complaints at Week 4

    Time frame: 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.

  14. Subjective Memory Complaints at Week 8

    Time frame: 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.

  15. Subjective Memory Complaints at Week 12

    Time frame: 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.

  16. Self-reported Sleep Quality at Week 4

    Time frame: 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.

  17. Self-reported Sleep Quality at Week 8

    Time frame: 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.

  18. Self-reported Sleep Quality at Week 12

    Time frame: 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.

  19. Self-reported Hot Flash Severity and Frequency at Week 4

    Time frame: 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.

  20. Self-reported Hot Flash Severity and Frequency at Week 8

    Time frame: 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.

  21. Self-reported Hot Flash Severity and Frequency at Week 12

    Time frame: 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.

  22. Anxiety Symptoms at Week 4

    Time frame: 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.

  23. Anxiety Symptoms at Week 8

    Time frame: 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.

  24. Anxiety Symptoms at Week 12

    Time frame: 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.

  25. Stress symptoms at Week 4

    Time frame: 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.

  26. Stress Symptoms at Week 8

    Time frame: 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.

  27. Stress Symptoms at Week 12

    Time frame: 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.

  28. Quality of Life Score at Week 4

    Time frame: 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.

  29. Quality of Life Score at Week 8

    Time frame: 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.

  30. Quality of Life Score at Week 12

    Time frame: 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.

  31. Change in Handgrip Strength from baseline to Week 12

    Time frame: Baseline and Week 12

    Assessed using a handgrip dynamometer.

  32. change in Leg Extensor Submaximal Strength from baseline to Week 12

    Time frame: Baseline and Week 12

    Assessed using the 4-6RM leg extensor strength test.

  33. Change in Isometric Mid-thigh Pull Strength from baseline to Week 12

    Time frame: Baseline and Week 12

    Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration

  34. 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

    Assessed as the number of reps completed in 30 seconds

  35. Change in Appendicular Lean Mass from baseline to Week 12

    Time frame: Baseline and Week 12

    Measured using dual X-ray Absorptiometry

  36. Felt-affect Visual Analogue score at week 4

    Time frame: Week 4

    To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact

  37. Felt-affect Visual Analogue score at week 8

    Time frame: Week 8

    To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact

  38. Felt-affect Visual Analogue score at week 12

    Time frame: Week 12

    To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact

  39. Exercise Enjoyment at week 1

    Time frame: 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.

  40. Exercise Enjoyment at week 4

    Time frame: 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.

  41. Exercise Enjoyment at week 8

    Time frame: 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.

  42. Exercise Enjoyment at week 12

    Time frame: 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.

  43. Change in Verbal Episodic Memory Performance from Pre- to Post-Supplement Intake in Week 1.

    Time frame: Pre- to 1 hour post- supplement intake in week 1

    Measured as the number of errors during the Cambridge Neuropsychological Test Automated Battery verbal Paired associates task.

  44. Change in Verbal Episodic Memory Performance From Pre- to Post-Supplement Intake in Week 12

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Measured as the number of errors during the Cambridge Neuropsychological Test Automated Battery verbal Paired associates task.

  45. Change in Working Memory Performance From Pre- to Post-Supplement Intake in Week 1

    Time frame: Pre- to 1 hour post- supplement intake in week 1

    Measured as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery backwards digit span task.

  46. Change In Working Memory Performance From Pre- to Post-Supplement Intake in Week 12.

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Measured as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery backwards digit span task.

  47. Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.

    Time frame: Pre- to 1 hour 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.

  48. Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Measured as the number of problems completed using the minimum number of moves during the Cambridge Neuropsychological Test Automated Battery stockings of Cambridge task.

  49. Change in Mood State From Pre- to Post- Supplement Intake in week 1

    Time frame: Pre- to 1 hour 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.

  50. Change in Mood State From Pre- to Post- Supplement Intake in Week 12

    Time frame: Pre- to 1 hour 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.

  51. Change in total body fat percentage from baseline to Week 12

    Time frame: Baseline and Week 12

    Measured using dual X-ray Absorptiometry

Other outcomes

  1. A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4

    Time frame: Week 4

    Analysed using LCMS from a serum sample.

  2. A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8

    Time frame: Week 8

    Analysed using LCMS from a serum sample.

  3. A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 12

    Time frame: Week 12

    Analysed using LCMS from a serum sample.

  4. Brain Derived Neurotrophic Factor at week 4

    Time frame: Week 4

    Analysed using ELISA from obtained serum sample

  5. Brain Derived Neurotrophic Factor at Week 8

    Time frame: Week 8

    Analysed using ELISA from obtained serum sample

  6. Brain Derived Neurotrophic Factor at Week 12

    Time frame: Week 12

    Analysed using ELISA from obtained serum sample

  7. Change From Baseline in Monoamine Oxidase A & B Activity at Week 4

    Time frame: Baseline to Week 4

    Analysed using Amplex assay kit.

  8. Change from baseline in Monoamine oxidase A & B activity at week 8

    Time frame: Baseline to week 8

    Analysed using Amplex assay kit.

  9. Change from baseline in Monoamine oxidase A & B activity at week 12

    Time frame: Baseline to week 12

    Analysed using Amplex assay kit.

  10. Change from baseline in plasma sarmentosin at week 4

    Time frame: Baseline to week 4

    Analysed using LCMS

  11. Change from baseline in plasma sarmentosin at week 8

    Time frame: Baseline to week 8

    Analysed using LCMS

  12. Change from baseline in plasma sarmentosin at week 12

    Time frame: Baseline to week 12

    Analysed using LCMS

  13. Inflammatory Cytokines (IL6, TNF-α) at week 4

    Time frame: Week 4

    Analysed using ELISA

  14. Inflammatory cytokines (e.g. IL6, TNF-α) at week 8

    Time frame: Week 8

    Analysed using ELISA

  15. Inflammatory cytokines (e.g. IL6, TNF-α) at week 12

    Time frame: Week 12

    Analysed using ELISA

  16. Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 1.

    Time frame: Pre- to 1 hour post- supplement intake in week 1

    Analysed using LCMS

  17. Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 12

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Analysed using LCMS

  18. Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 1.

    Time frame: Pre- to 1 hour post- supplement intake in week 1

    Analysed using LCMS

  19. Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 12

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Analysed using LCMS

  20. Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 1

    Time frame: Pre- to 1 hour post- supplement intake in week 1

    Analysed using amplex assay kits

  21. Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 12

    Time frame: Pre- to 1 hour post- supplement intake in week 12

    Analysed using amplex assay kits

Study contacts

Contact information is provided by the study sponsor or research team.

Harriet Cannell

CONTACT

[email protected]

+447805576688

Theocharis Ispogolou

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Leeds Beckett University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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