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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Supplement Only | Placebo Comparator | Two placebo capsules to be consumed by participants daily |
|
| Placebo Supplement and Resistance Training | Experimental | Participants will consume two placebo supplements daily, and perform structured resistance training three times per week. |
|
| Active Supplement Only | Experimental | Participants will consume two capsules of the Sarmentosin - L-theanine supplement daily. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarmentosin - L- theanine | Dietary Supplement | Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Pre- to 1 hour post- supplement intake at week 12 of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Verbal Episodic Memory Performance at Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4 | Analysed using LCMS from a serum sample. | Week 4 |
| A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8 |
Inclusion criteria
Exclusion criteria
Participants must have been assigned female at birth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harriet Cannell | Contact | +447805576688 | H.cannell@leedsbeckett.ac.uk | |
| Theocharis Ispogolou | Contact | T.Ispoglou@leedsbeckett.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carnegie School of Sport | Recruiting | Leeds | North Humberside | LS2 3AE | United Kingdom |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D009043 | Motor Activity |
| D019584 | Hot Flashes |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Masking will only be applied to supplement allocation. All parties will be aware of their exercise allocation.
| 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. |
|
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| Placebo Supplement | Dietary Supplement | Capsules matched for taste and appearance, without any active ingredients. |
|
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 12 |
| Change in Handgrip Strength from baseline to Week 12 | Assessed using a handgrip dynamometer. | Baseline and Week 12 |
| change in Leg Extensor Submaximal Strength from baseline to Week 12 | Assessed using the 4-6RM leg extensor strength test. | 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 | 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 | baseline and Week 12 |
| Change in Appendicular Lean Mass from baseline to Week 12 | Measured using dual X-ray Absorptiometry | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | Baseline and Week 12 |
Analysed using LCMS from a serum sample.
| 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. | Week 12 |
| Brain Derived Neurotrophic Factor at week 4 | Analysed using ELISA from obtained serum sample | Week 4 |
| Brain Derived Neurotrophic Factor at Week 8 | Analysed using ELISA from obtained serum sample | Week 8 |
| Brain Derived Neurotrophic Factor at Week 12 | Analysed using ELISA from obtained serum sample | Week 12 |
| Change From Baseline in Monoamine Oxidase A & B Activity at Week 4 | Analysed using Amplex assay kit. | Baseline to Week 4 |
| Change from baseline in Monoamine oxidase A & B activity at week 8 | Analysed using Amplex assay kit. | Baseline to week 8 |
| Change from baseline in Monoamine oxidase A & B activity at week 12 | Analysed using Amplex assay kit. | Baseline to week 12 |
| Change from baseline in plasma sarmentosin at week 4 | Analysed using LCMS | Baseline to week 4 |
| Change from baseline in plasma sarmentosin at week 8 | Analysed using LCMS | Baseline to week 8 |
| Change from baseline in plasma sarmentosin at week 12 | Analysed using LCMS | Baseline to week 12 |
| Inflammatory Cytokines (IL6, TNF-α) at week 4 | Analysed using ELISA | Week 4 |
| Inflammatory cytokines (e.g. IL6, TNF-α) at week 8 | Analysed using ELISA | Week 8 |
| Inflammatory cytokines (e.g. IL6, TNF-α) at week 12 | Analysed using ELISA | Week 12 |
| Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 1. | Analysed using LCMS | 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 | 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 | 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 | 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 | 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 | Pre- to 1 hour post- supplement intake in week 12 |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |