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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
72
A capsule containing 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.
Capsule matched for taste and appearance, without any active ingredients.
Carnegie School of Sport
Leeds, North Humberside, United Kingdom
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 number of problems completed using the minimum number of moves during the Cambridge Neuropsychological Test Automated Battery stockings of Cambridge task
Time frame: Week 4
Spatial Planning and Working Memory Performance at week 8
Assessed 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: Week 8
Spatial Planning and Working Memory Performance at Week 12
Assessed 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: 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
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