The Use of Resistance Training and a Plant-Based Supplement to Improve the Symptoms and Musculoskeletal Health of Perimenopausal Women

Not Applicable

Not yet recruiting

• Conditions: Perimenopause; Menopause

• Registration Number: NCT07135232
• Lead Sponsor: Leeds Beckett University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-09-08
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 72

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 that contain L-theanine (e.g. Green tea) or blackcurrant and are willing to limit dietary sources throughout the intervention period.

7. 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. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
6. Obesity (BMI >30 or for South Asian Ethinicity BMI> 27.5)
7. Food allergy or intolerance to study products.
8. Smoking or use of recreational drugs.
9. Alcohol intake exceeding 2 standard units per (e.g. >1 standard drink).
10. Pregnant or planning to conceive during the trial.
11. High habitual caffeine intake (>400 mg/day)
12. Recent participation in another clinical trial involving dietary or exercise interventions (<6 months).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depressive Symptom Score at week 4	Week 4	Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. Higher scores indicate more severe depressive symptoms.
Depressive Symptom Score at Week 8	Baseline week 8	Assessed using the depressive sub-scale of the Depression, Anxiety and stress scale - 21 items. 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. 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 CANTAB 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 CANTAB rapid visual information processing test.

Secondary Outcome Measures

Name	Time	Method
Verbal Episodic Memory Performance at Week 4	Week 4	Assessed as the number of errors made on the CANTAB verbal paired associates task.
Verbal Episodic Memory Performance at Week 8	Week 8	Assessed as the number of errors made on the CANTAB verbal paired associates task
Verbal Episodic Memory Performance at Week 12	Week 12	Assessed as the number of errors made on the CANTAB verbal paired associates task.
Working Memory Performance at Week 4	Week 4	Assessed as the longest sequence successfully completed during the CANTAB digit span task.
Working Memory Performance at Week 8	Week 8	Assessed as the longest sequence successfully completed during the CANTAB digit span task
Working Memory Performance at Week 12	Week 12	Assessed as the longest sequence successfully completed during the CANTAB digit span task.
Spatial Planning and Working Memory Performance at Week 4	Week 4	Assessed as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task
Spatial Planning and Working Memory Performance at week 8	Week 8	Assessed as the number of problems completed using the minimum number of moves during the CANTAB stockings of Cambridge task
Spatial Planning and Working Memory Performance at Week 12	Week 12	Assessed as the number of problems completed using the minimum number of moves during the CANTAB 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 CANTAB 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 CANTAB 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 CANTAB rapid visual information processing test.
Subjective Memory Complaints at Week 4	Week 4	Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.
Subjective Memory Complaints at Week 8	Week 8	Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.
Subjective Memory Complaints at Week 12	Week 12	Assessed using the Everyday Memory Questionnaire - Revised. Higher scores signify greater memory complaints.
Self-reported Sleep Quality at Week 4	Week 4	Assessed using the Pittsburgh sleep quality index. Higher scores signify poorer subjective sleep quality.
Self-reported Sleep Quality at Week 8	Week 8	Assessed using the Pittsburgh sleep quality index. Higher scores signify poorer subjective sleep quality.
Self-reported Sleep Quality at Week 12	Week 12	Assessed using the Pittsburgh sleep quality index. 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 (higher score = more problematic)
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 (higher score = more problematic)
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 (higher score = more problematic)
Anxiety Symptoms at Week 4	Week 4	Assessed using the anxiety sub-scale of the Depression, Anxiety and stress scale - 21 items. 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. 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. 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. 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. 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. 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. Higher score = worse quality of life. The overall score can be split into vasomotor, psychosocial, physical and sexual domains.
Quality of Life Score at Week 8	Week 8	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.
Quality of Life Score at Week 12	Week 12	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.
Handgrip Strength at Week 4	Week 4	Assessed using a handgrip dynamometer.
Handgrip Strength at Week 8	Week 8	Assessed using a handgrip dynamometer.
Handgrip Strength at Week 12	Week 12	Assessed using a handgrip dynamometer.
Leg Extensor Submaximal Strength at Week 4	Week 4	Assessed using the 4-6RM leg extensor strength test.
Leg Extensor Submaximal Strength at Week 8	Week 8	Assessed using the 4-6RM leg extensor strength test.
Leg Extensor Submaximal Strength at Week 12	Week 12	Assessed using the 4-6RM leg extensor strength test.
Isometric Mid-thigh Pull Strength at Week 4	Week 4	Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration.
Isometric Mid-thigh Pull Strength at Week 8	Week 8	Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration
Isometric Mid-thigh Pull Strength at Week 12	Week 12	Assessed using a portable back and leg dynamometer in a standing horizontal pull configuration
Number of Reps Completed in the 30 Second Sit-to-stand Test at Week 4	Week 4	Assessed as the number of reps completed in 30 seconds
Number of Reps Completed in the 30 Second Sit-to-stand Test at week 8	Week 8	Assessed as the number of reps completed in 30 seconds.
Number of Reps Completed in the 30 Second Sit-to-stand Test at week 12	Week 12	Assessed as the number of reps completed in 30 seconds
Appendicular lean mass at week 8	Week 8	Measured using dual X-ray Absorptiometry
Appendicular Lean Mass at Week 12	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. Higher scores indicate greater exercise enjoyment.
Exercise Enjoyment at week 4	Week 4	Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.
Exercise Enjoyment at week 8	Week 8	Assessed as overall score on the physical activity enjoyment scale. Higher scores indicate greater exercise enjoyment.
Exercise Enjoyment at week 12	Week 12	Assessed as overall score on the physical activity enjoyment scale. 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 CANTAB 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 CANTAB 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 CANTAB 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 CANTAB 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 12	Measured as the number of problems completed using the minimum number of moves during the CANTAB 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. Higher score = greater experience of the 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. Higher score = greater experience of the mood state.

Trial Locations

Locations (1)

Carnegie School of Sport; 🇬🇧 Leeds, North Humberside, United Kingdom