The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Mu… (NCT07135232) | Clinical Trial Compass
RecruitingNot Applicable
The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
United Kingdom72 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range40 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Perimenopausal women between 40 - 55 years
✓. 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).
✓. Not on any HRT or hormonal contraception for at least one year before initiation of the study.
✓. Able to attend laboratory visits and commit to the intervention schedule for 6 months.
✓. Willing to provide blood samples
✓. Not regularly consuming any dietary supplements containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention.
✓. Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea).
✓. Willing and able to provide written informed consent
Exclusion criteria
✕. Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation.
What they're measuring
1
Depressive Symptom Score at week 4
Timeframe: Week 4
2
Depressive Symptom Score at Week 8
Timeframe: Week 8
3
Depressive Symptom Score at Week 12
Timeframe: Week 12
4
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.
5
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.
✕. Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months).