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New treatment option for Perimenopause
Official title The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
ClinicalTrials.gov ID: NCT07135232
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Leeds, North Humberside, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeds, North Humberside, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.