Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT07135232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Resistance Training and a Plant-Based Supplement to Improve the Symptoms and Musculoskeletal Health of Perimenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Masking will only be applied to supplement allocation. All parties will be aware of their exercise allocation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4', 'timeFrame': 'Week 4', 'description': 'Analysed using LCMS from a serum sample.'}, {'measure': 'A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8', 'timeFrame': 'Week 8', 'description': 'Analysed using LCMS from a serum sample.'}, {'measure': 'A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 12', 'timeFrame': 'Week 12', 'description': 'Analysed using LCMS from a serum sample.'}, {'measure': 'Brain Derived Neurotrophic Factor at week 4', 'timeFrame': 'Week 4', 'description': 'Analysed using ELISA from obtained serum sample'}, {'measure': 'Brain Derived Neurotrophic Factor at Week 8', 'timeFrame': 'Week 8', 'description': 'Analysed using ELISA from obtained serum sample'}, {'measure': 'Brain Derived Neurotrophic Factor at Week 12', 'timeFrame': 'Week 12', 'description': 'Analysed using ELISA from obtained serum sample'}, {'measure': 'Change From Baseline in Monoamine Oxidase A & B Activity at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Analysed using Amplex assay kit.'}, {'measure': 'Change from baseline in Monoamine oxidase A & B activity at week 8', 'timeFrame': 'Baseline to week 8', 'description': 'Analysed using Amplex assay kit.'}, {'measure': 'Change from baseline in Monoamine oxidase A & B activity at week 12', 'timeFrame': 'Baseline to week 12', 'description': 'Analysed using Amplex assay kit.'}, {'measure': 'Change from baseline in plasma sarmentosin at week 4', 'timeFrame': 'Baseline to week 4', 'description': 'Analysed using LCMS'}, {'measure': 'Change from baseline in plasma sarmentosin at week 8', 'timeFrame': 'Baseline to week 8', 'description': 'Analysed using LCMS'}, {'measure': 'Change from baseline in plasma sarmentosin at week 12', 'timeFrame': 'Baseline to week 12', 'description': 'Analysed using LCMS'}, {'measure': 'Inflammatory Cytokines (IL6, TNF-α) at week 4', 'timeFrame': 'Week 4', 'description': 'Analysed using ELISA'}, {'measure': 'Inflammatory cytokines (e.g. IL6, TNF-α) at week 8', 'timeFrame': 'Week 8', 'description': 'Analysed using ELISA'}, {'measure': 'Inflammatory cytokines (e.g. IL6, TNF-α) at week 12', 'timeFrame': 'Week 12', 'description': 'Analysed using ELISA'}, {'measure': 'Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 1.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1', 'description': 'Analysed using LCMS'}, {'measure': 'Change in Sarmentosin Levels From Pre- to Post-Supplement Intake in Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Analysed using LCMS'}, {'measure': 'Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 1.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1', 'description': 'Analysed using LCMS'}, {'measure': 'Change in L-theanine Levels From Pre- to Post-Supplement Intake in Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Analysed using LCMS'}, {'measure': 'Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 1', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1', 'description': 'Analysed using amplex assay kits'}, {'measure': 'Change in Plasma Monoamine Oxidase A and B Activity From Pre- to Post-Supplement Intake in Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Analysed using amplex assay kits'}], 'primaryOutcomes': [{'measure': 'Depressive Symptom Score at week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe depressive symptoms.'}, {'measure': 'Depressive Symptom Score at Week 8', 'timeFrame': 'Baseline week 8', 'description': 'Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe depressive symptoms.'}, {'measure': 'Depressive Symptom Score at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe depressive symptoms.'}, {'measure': 'Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1', 'timeFrame': 'Pre- to 1 hour post- supplement intake at week 1 of the intervention.', 'description': "Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the CANTAB rapid visual information processing test."}, {'measure': 'Change in Sustained Attention Pre- to Post-Supplement Intake at Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake at week 12 of the intervention.', 'description': "Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the CANTAB rapid visual information processing test."}], 'secondaryOutcomes': [{'measure': 'Verbal Episodic Memory Performance at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed as the number of errors made on the CANTAB verbal paired associates task.'}, {'measure': 'Verbal Episodic Memory Performance at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed as the number of errors made on the CANTAB verbal paired associates task'}, {'measure': 'Verbal Episodic Memory Performance at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed as the number of errors made on the CANTAB verbal paired associates task.'}, {'measure': 'Working Memory Performance at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed as the longest sequence successfully completed during the CANTAB digit span task.'}, {'measure': 'Working Memory Performance at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed as the longest sequence successfully completed during the CANTAB digit span task'}, {'measure': 'Working Memory Performance at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed as the longest sequence successfully completed during the CANTAB digit span task.'}, {'measure': 'Spatial Planning and Working Memory Performance at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task'}, {'measure': 'Spatial Planning and Working Memory Performance at week 8', 'timeFrame': 'Week 8', 'description': 'Assessed as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task'}, {'measure': 'Spatial Planning and Working Memory Performance at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task.'}, {'measure': 'Sustained Attention Performance at Week 4', 'timeFrame': 'Week 4', 'description': "Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the CANTAB rapid visual information processing test."}, {'measure': 'Sustained Attention Performance at week 8', 'timeFrame': 'Week 8', 'description': "Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the CANTAB rapid visual information processing test"}, {'measure': 'Sustained Attention Performance at Week 12', 'timeFrame': 'Week 12', 'description': "Assessed as the signal detection measure of a subject's sensitivity to the target sequence (A') during the CANTAB rapid visual information processing test."}, {'measure': 'Subjective Memory Complaints at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.'}, {'measure': 'Subjective Memory Complaints at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.'}, {'measure': 'Subjective Memory Complaints at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.'}, {'measure': 'Self-reported Sleep Quality at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the Pittsburgh sleep quality index. Higher scores signify poorer subjective sleep quality.'}, {'measure': 'Self-reported Sleep Quality at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the Pittsburgh sleep quality index. Higher scores signify poorer subjective sleep quality.'}, {'measure': 'Self-reported Sleep Quality at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the Pittsburgh sleep quality index. Higher scores signify poorer subjective sleep quality.'}, {'measure': 'Self-reported Hot Flash Severity and Frequency at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating (higher score = more problematic)'}, {'measure': 'Self-reported Hot Flash Severity and Frequency at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating (higher score = more problematic)'}, {'measure': 'Self-reported Hot Flash Severity and Frequency at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the Hot flush rating scale. Split into two sub-sections: frequency and problem rating (higher score = more problematic)'}, {'measure': 'Anxiety Symptoms at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the anxiety sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe anxiety symptoms.'}, {'measure': 'Anxiety Symptoms at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the anxiety sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe anxiety symptoms.'}, {'measure': 'Anxiety Symptoms at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the anxiety sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe anxiety symptoms.'}, {'measure': 'Stress symptoms at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the stress sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe stress symptoms.'}, {'measure': 'Stress Symptoms at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the stress sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe stress symptoms.'}, {'measure': 'Stress Symptoms at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the stress sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe stress symptoms.'}, {'measure': 'Quality of Life Score at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the menopause specific quality of life questionnaire. Higher score = worse quality of life. The overall score can be split into vasomotor, psychosocial, physical and sexual domains.'}, {'measure': 'Quality of Life Score at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the menopause specific quality of life questionnaire. Higher score = worse quality of life. The overall score can be split into vasomotor, psychosocial, physical and sexual domains.'}, {'measure': 'Quality of Life Score at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the menopause specific quality of life questionnaire. Higher score = worse quality of life. The overall score can be split into vasomotor, psychosocial, physical and sexual domains.'}, {'measure': 'Handgrip Strength at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using a handgrip dynamometer.'}, {'measure': 'Handgrip Strength at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using a handgrip dynamometer.'}, {'measure': 'Handgrip Strength at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using a handgrip dynamometer.'}, {'measure': 'Leg Extensor Submaximal Strength at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using the 4-6RM leg extensor strength test.'}, {'measure': 'Leg Extensor Submaximal Strength at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using the 4-6RM leg extensor strength test.'}, {'measure': 'Leg Extensor Submaximal Strength at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using the 4-6RM leg extensor strength test.'}, {'measure': 'Isometric Mid-thigh Pull Strength at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration.'}, {'measure': 'Isometric Mid-thigh Pull Strength at Week 8', 'timeFrame': 'Week 8', 'description': 'Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration'}, {'measure': 'Isometric Mid-thigh Pull Strength at Week 12', 'timeFrame': 'Week 12', 'description': 'Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration'}, {'measure': 'Number of Reps Completed in the 30 Second Sit-to-stand Test at Week 4', 'timeFrame': 'Week 4', 'description': 'Assessed as the number of reps completed in 30 seconds'}, {'measure': 'Number of Reps Completed in the 30 Second Sit-to-stand Test at week 8', 'timeFrame': 'Week 8', 'description': 'Assessed as the number of reps completed in 30 seconds.'}, {'measure': 'Number of Reps Completed in the 30 Second Sit-to-stand Test at week 12', 'timeFrame': 'Week 12', 'description': 'Assessed as the number of reps completed in 30 seconds'}, {'measure': 'Appendicular lean mass at week 8', 'timeFrame': 'Week 8', 'description': 'Measured using dual X-ray Absorptiometry'}, {'measure': 'Appendicular Lean Mass at Week 12', 'timeFrame': 'Week 12', 'description': 'Measured using dual X-ray Absorptiometry'}, {'measure': 'Felt-affect Visual Analogue score at week 4', 'timeFrame': 'Week 4', 'description': 'To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact'}, {'measure': 'Felt-affect Visual Analogue score at week 8', 'timeFrame': 'Week 8', 'description': 'To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact'}, {'measure': 'Felt-affect Visual Analogue score at week 12', 'timeFrame': 'Week 12', 'description': 'To assess the perceived impact of the supplement on mood and cognitive function. Higher scores indicate greater perceived impact'}, {'measure': 'Exercise Enjoyment at week 1', 'timeFrame': 'Week 1', 'description': 'Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.'}, {'measure': 'Exercise Enjoyment at week 4', 'timeFrame': 'Week 4', 'description': 'Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.'}, {'measure': 'Exercise Enjoyment at week 8', 'timeFrame': 'Week 8', 'description': 'Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.'}, {'measure': 'Exercise Enjoyment at week 12', 'timeFrame': 'Week 12', 'description': 'Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.'}, {'measure': 'Change in Verbal Episodic Memory Performance from Pre- to Post-Supplement Intake in Week 1.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1', 'description': 'Measured as the number of errors during the CANTAB verbal Paired associates task.'}, {'measure': 'Change in Verbal Episodic Memory Performance From Pre- to Post-Supplement Intake in Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Measured as the number of errors during the CANTAB verbal Paired associates task.'}, {'measure': 'Change in Working Memory Performance From Pre- to Post-Supplement Intake in Week 1', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1', 'description': 'Measured as the longest sequence successfully completed during the CANTAB backwards digit span task.'}, {'measure': 'Change In Working Memory Performance From Pre- to Post-Supplement Intake in Week 12.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Measured as the longest sequence successfully completed during the CANTAB backwards digit span task.'}, {'measure': 'Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1.', 'description': 'Measured as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task.'}, {'measure': 'Change in Spatial Planning and Working Memory Performance From Pre- to Post-Supplement Intake in Week 1.', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Measured as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task.'}, {'measure': 'Change in Mood State From Pre- to Post- Supplement Intake in week 1', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 1.', 'description': 'Assessed using the Bond-Lader visual analogue scale. Scores can be split into alertness, contentment and calmness. Higher score = greater experience of the mood state.'}, {'measure': 'Change in Mood State From Pre- to Post- Supplement Intake in Week 12', 'timeFrame': 'Pre- to 1 hour post- supplement intake in week 12', 'description': 'Assessed using the Bond-Lader visual analogue scale. Scores can be split into alertness, contentment and calmness. Higher score = greater experience of the mood state.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Perimenopause', 'Menopause']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to evaluate are:\n\n1. 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)?\n2. 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)?\n3. What mechanisms may be contributing to the results?\n\nParticipants will be split into four groups to allow the researchers to answer the above questions. These are:\n\n1. The nutritional supplement + resistance training\n2. The nutritional supplement only\n3. The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training\n4. The Placebo supplement only.\n\nParticipants will:\n\n* Take their allocated supplement daily and perform home-based strength exercise 3 times per week (for exercise groups), for 12 weeks.\n* Attend the laboratory at the beginning and end of the 12 weeks to assess cognitive function and mood following acute intake of the supplement.\n* Attend the laboratory every 4 weeks during the 12 week period, for assessment of cognitive function, symptom severity and muscle health.\n* Provide a blood sample at each visit for assessment of mechanistic pathways.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Participants must have been assigned female at birth.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Perimenopausal women between 40 - 55 years\n2. 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).\n3. Not on any HRT or hormonal contraception for at least one year before initiation of the study.\n4. Able to attend laboratory visits and commit to the intervention schedule for 6 months.\n5. Willing to provide blood samples\n6. Not regularly consuming any dietary supplements that contain L-theanine (e.g. Green tea) or blackcurrant and are willing to limit dietary sources throughout the intervention period.\n\n8\\. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\\>160/100 mmHg), or other conditions that prevent safe exercise participation.\n2. Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months).\n3. Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy).\n4. Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction).\n5. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.\n6. Obesity (BMI \\>30 or for South Asian Ethinicity BMI\\> 27.5)\n7. Food allergy or intolerance to study products.\n8. Smoking or use of recreational drugs.\n9. Alcohol intake exceeding 2 standard units per (e.g. \\>1 standard drink).\n10. Pregnant or planning to conceive during the trial.\n11. High habitual caffeine intake (\\>400 mg/day)\n12. Recent participation in another clinical trial involving dietary or exercise interventions (\\<6 months)."}, 'identificationModule': {'nctId': 'NCT07135232', 'briefTitle': 'The Use of Resistance Training and a Plant-Based Supplement to Improve the Symptoms and Musculoskeletal Health of Perimenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Leeds Beckett University'}, 'officialTitle': 'The Effects of Resistance Training and a Sarmentosin - L-theanine Supplement on Perimenopausal Symptoms and Musculoskeletal Health: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'AM004156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Supplement Only', 'description': 'One placebo capsule to be consumed by participants daily', 'interventionNames': ['Dietary Supplement: Placebo Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo Supplement and Resistance Training', 'description': 'Participants will consume one placebo supplement daily, and perform structured resistance training three times per week.', 'interventionNames': ['Other: Resistance Training', 'Dietary Supplement: Placebo Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Active Supplement Only', 'description': 'Participants will consume one capsule of the Sarmentosin - L-theanine supplement daily.', 'interventionNames': ['Dietary Supplement: Sarmentosin - L- theanine']}, {'type': 'EXPERIMENTAL', 'label': 'Active Supplement and Resistance Training', 'description': 'Participants will consume one capsule of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.', 'interventionNames': ['Dietary Supplement: Sarmentosin - L- theanine', 'Other: Resistance Training']}], 'interventions': [{'name': 'Sarmentosin - L- theanine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A capsule containing 275.184 mg of Sarmentosin and 400mg of L-theanine', 'armGroupLabels': ['Active Supplement Only', 'Active Supplement and Resistance Training']}, {'name': 'Resistance Training', 'type': 'OTHER', 'otherNames': ['Strength Training', 'Resistance Exercise', 'Strength Exercise'], 'description': 'Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.', 'armGroupLabels': ['Active Supplement and Resistance Training', 'Placebo Supplement and Resistance Training']}, {'name': 'Placebo Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule matched for taste and appearance, without any active ingredients.', 'armGroupLabels': ['Placebo Supplement Only', 'Placebo Supplement and Resistance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 3AE', 'city': 'Leeds', 'state': 'North Humberside', 'country': 'United Kingdom', 'contacts': [{'name': 'Harriet Cannell', 'role': 'CONTACT', 'email': 'H.cannell@leedsbeckett.ac.uk', 'phone': '+44 7805576688'}, {'name': 'Theocharis Ispogolou', 'role': 'CONTACT', 'email': 'T.Ispoglou@leedsbeckett.ac.uk'}], 'facility': 'Carnegie School of Sport', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Harriet Cannell', 'role': 'CONTACT', 'email': 'H.cannell@leedsbeckett.ac.uk', 'phone': '+447805576688'}, {'name': 'Theocharis Ispogolou', 'role': 'CONTACT', 'email': 'T.Ispoglou@leedsbeckett.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leeds Beckett University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alphagen NZ Limited', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Researcher', 'investigatorFullName': 'Harriet Cannell', 'investigatorAffiliation': 'Leeds Beckett University'}}}}