Overview
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:
- 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)?
- 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)?
- 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:
- The nutritional supplement + resistance training
- The nutritional supplement only
- The placebo supplement (A look alike capsule that contains no active ingredients) and resistance training
- 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.
Eligibility
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.
- Clinically diagnosed mental health disorders (e.g., bipolar disorder, schizophrenia, severe depression requiring medication adjustment within the last 6 months).
- Neurological conditions affecting cognitive function (e.g., Parkinson's disease, multiple sclerosis, epilepsy).
- Endocrine disorders that could impact hormonal fluctuations or metabolism (e.g., uncontrolled diabetes, thyroid dysfunction).
- History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months
- Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
- Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5)
- Food allergy or intolerance to study products.
- Use of illicit drugs.
- Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks).
- Pregnant or planning to conceive during the trial.
- High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)