The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorLeeds Beckett University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Sarmentosin - L- theanine
Dietary supplementTwo capsules to give an overall dose of 20 mg of Sarmentosin and 400mg of L-theanine
Resistance Training
Other interventionHome-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Placebo Supplement
Dietary supplementCapsules matched for taste and appearance, without any active ingredients.
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Placebo Supplement OnlyPlacebo comparator 1 intervention
Group B: Placebo Supplement and Resistance TrainingExperimental treatment 2 interventions
Group C: Active Supplement OnlyExperimental treatment 1 intervention
Group D: Active Supplement and Resistance TrainingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Depressive Symptom Score at 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.
Time frame
Week 42
Depressive Symptom Score at 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.
Time frame
Week 83
Depressive Symptom Score at 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.
Time frame
Week 124
Change in Sustained Attention Pre- to Post-Supplement Intake at Week 1
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.
Time frame
Pre- to 1 hour post- supplement intake at week 1 of the intervention.Secondary outcomes
1
Verbal Episodic Memory Performance at Week 4
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.
Time frame
Week 42
Verbal Episodic Memory Performance at Week 8
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task
Time frame
Week 83
Verbal Episodic Memory Performance at Week 12
Assessed as the number of errors made on the Cambridge Neuropsychological Test Automated Battery verbal paired associates task.
Time frame
Week 124
Working Memory Performance at Week 4
Assessed as the longest sequence successfully completed during the Cambridge Neuropsychological Test Automated Battery digit span task.
Time frame
Week 4Other outcomes
1
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 4
Analysed using LCMS from a serum sample.
Time frame
Week 42
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 8
Analysed using LCMS from a serum sample.
Time frame
Week 83
A Panel of Serum Steroid Hormones (e.g. Oestradiol, Progesterone, Testosterone and Cortisol) at Week 12
Analysed using LCMS from a serum sample.
Time frame
Week 124
Brain Derived Neurotrophic Factor at week 4
Analysed using ELISA from obtained serum sample
Time frame
Week 4Sponsors and contacts
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Source ClinicalTrials.gov