Menopause, Perimenopause
Conditions
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
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTSarmentosin - L- theanine
Two capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
OTHERResistance Training
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
DIETARY_SUPPLEMENTPlacebo Supplement
Capsules matched for taste and appearance, without any active ingredients.
Sponsors
Leeds Beckett University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Masking will only be applied to supplement allocation. All parties will be aware of their exercise allocation.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Perimenopausal women between 40 - 55 years 2. 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). 3. Not on any HRT or hormonal contraception for at least one year before initiation of the study. 4. Able to attend laboratory visits and commit to the intervention schedule for 6 months. 5. Willing to provide blood samples 6. Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention. 7. Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea). 8. Willing and able to provide written informed consent
Exclusion criteria
1. Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation. 2. Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months). 3. Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy). 4. Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction). 5. History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months 6. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers. 7. Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5) 8. Food allergy or intolerance to study products. 9. Use of illicit drugs. 10. Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks). 11. Pregnant or planning to conceive during the trial. 12. High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Score at week 4 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Verbal Episodic Memory Performance at Week 4 | Week 4 | Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task. |
| Verbal Episodic Memory Performance at Week 8 | Week 8 | Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task |
| Verbal Episodic Memory Performance at Week 12 | Week 12 | Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task. |
| Working Memory Performance at Week 4 | Week 4 | Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task. |
| Working Memory Performance at Week 8 | Week 8 | Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task |
| Working Memory Performance at Week 12 | Week 12 | Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task. |
| Spatial Planning and Working Memory Performance at Week 4 | 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. |
| Spatial Planning and Working Memory Performance at week 8 | 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. |
| Spatial Planning and Working Memory Performance at Week 12 | 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. |
| Sustained Attention Performance at Week 4 | 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. |
| Sustained Attention Performance at week 8 | 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 |
| Sustained Attention Performance at Week 12 | 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. |
| Subjective Memory Complaints at Week 4 | 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. |
| Subjective Memory Complaints at Week 8 | 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. |
| Subjective Memory Complaints at Week 12 | 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. |
| Self-reported Sleep Quality at Week 4 | 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. |
| Self-reported Sleep Quality at Week 8 | 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. |
| Self-reported Sleep Quality at Week 12 | 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. |
| Self-reported Hot Flash Severity and Frequency at Week 4 | 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. |
| Self-reported Hot Flash Severity and Frequency at Week 8 | 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. |
| Self-reported Hot Flash Severity and Frequency at Week 12 | 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. |
| Anxiety Symptoms at Week 4 | 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. |
| Anxiety Symptoms at Week 8 | 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. |
| Anxiety Symptoms at Week 12 | 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. |
| Stress symptoms at Week 4 | 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. |
| Stress Symptoms at Week 8 | 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. |
| Stress Symptoms at Week 12 | 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. |
| Quality of Life Score at Week 4 | 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. |
| Quality of Life Score at Week 8 | 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. |
| Quality of Life Score at Week 12 | 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. |
| Change in Handgrip Strength from baseline to Week 12 | Baseline and Week 12 | Assessed using a handgrip dynamometer. |
| change in Leg Extensor Submaximal Strength from baseline to Week 12 | Baseline and Week 12 | Assessed using the 4-6RM leg extensor strength test. |
| Change in Isometric Mid-thigh Pull Strength from baseline to Week 12 | Baseline and Week 12 | Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration |
| Change in the Number of Reps Completed in the 30 Second Sit-to-stand Test from baseline to week 12 | baseline and Week 12 | Assessed as the number of reps completed in 30 seconds |
| Change in Appendicular Lean Mass from baseline to Week 12 | Baseline and Week 12 | Measured using dual X-ray Absorptiometry |
| Felt-affect Visual Analogue score at week 4 | Week 4 | To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact |
| Felt-affect Visual Analogue score at week 8 | Week 8 | To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact |
| Felt-affect Visual Analogue score at week 12 | Week 12 | To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact |
| Exercise Enjoyment at week 1 | 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. |
| Exercise Enjoyment at week 4 | 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. |
| Exercise Enjoyment at week 8 | 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. |
| Exercise Enjoyment at week 12 | 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. |
| Change in Verbal Episodic Memory Performance from Pre- to Post-Supplement Intake in Week 1. | 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. |
| Change in Verbal Episodic Memory Performance From Pre- to Post-Supplement Intake in Week 12 | 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. |
| Change in Working Memory Performance From Pre- to Post-Supplement Intake in Week 1 | 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. |
| Change In Working Memory Performance From Pre- to Post-Supplement Intake in Week 12. | 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. |
| Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1. | 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. |
| Change in Mood State From Pre- to Post- Supplement Intake in week 1 | 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. |
| Change in Mood State From Pre- to Post- Supplement Intake in Week 12 | 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. |
| Change in total body fat percentage from baseline to Week 12 | Baseline and Week 12 | Measured using dual X-ray Absorptiometry |
Countries
United Kingdom
Contacts
CONTACTHarriet Cannell
CONTACTTheocharis Ispogolou
Outcome results
None listed