The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
NCT ID: NCT07135232
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2026-01-01
2026-12-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Placebo Supplement Only
One placebo capsule to be consumed by participants daily
Placebo Supplement
Capsule matched for taste and appearance, without any active ingredients.
Placebo Supplement and Resistance Training
Participants will consume one placebo supplement daily, and perform structured resistance training three times per week.
Resistance Training
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Placebo Supplement
Capsule matched for taste and appearance, without any active ingredients.
Active Supplement Only
Participants will consume one capsule of the Sarmentosin - L-theanine supplement daily.
Sarmentosin - L- theanine
A capsule containing 20 mg of Sarmentosin and 400mg of L-theanine
Active Supplement and Resistance Training
Participants will consume one capsule of the Sarmentosin - L-theanine supplement daily and perform structured resistance training three times per week.
Sarmentosin - L- theanine
A capsule containing 20 mg of Sarmentosin and 400mg of L-theanine
Resistance Training
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Interventions
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Sarmentosin - L- theanine
A capsule containing 20 mg of Sarmentosin and 400mg of L-theanine
Resistance Training
Home-based Resistance training. Exercises will target the lower and upper body and utilise body weight, resistance bands, dumbbells and push-up handles.
Placebo Supplement
Capsule matched for taste and appearance, without any active ingredients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 containing concentrated sarmentosin, L-theanine or other compounds that may interfere with the study intervention.
7. Willing to limit dietary intake of Sarmentosin (e.g. Blackcurrant) and L-theanine (e.g. green tea/ black tea).
8. Willing and able to provide written informed consent
Exclusion Criteria
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. History of major musculoskeletal injuries (e.g., fractures, joint replacement) within the past 6 months
6. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
7. Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5)
8. Food allergy or intolerance to study products.
9. Use of illicit drugs.
10. Alcohol intake exceeding the government guidelines of 14 standard units per week (Equivalent of 6 standard drinks).
11. Pregnant or planning to conceive during the trial.
12. High habitual caffeine intake (\>400 mg/day which is approximately 4-5 cups of coffee)
40 Years
55 Years
FEMALE
Yes
Sponsors
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Leeds Beckett University
OTHER
Responsible Party
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Harriet Cannell
Doctoral Researcher
Locations
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Carnegie School of Sport
Leeds, North Humberside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AM004156
Identifier Type: -
Identifier Source: org_study_id
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