Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT07135232
Eligibility Criteria:
Inclusion Criteria:
1. Perimenopausal women between 40 - 55 years
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 that contain L-theanine (e.g. Green tea) or blackcurrant and are willing to limit dietary sources throughout the intervention period.
8\. Willing and able to provide written informed consent.
Exclusion Criteria:
1. Diagnosed cardiovascular disease (CVD), uncontrolled hypertension (\>160/100 mmHg), or other conditions that prevent safe exercise participation.
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. Regular use of medications that could interfere with study outcomes, including antidepressants, corticosteroids, beta-blockers.
6. Obesity (BMI \>30 or for South Asian Ethinicity BMI\> 27.5)
7. Food allergy or intolerance to study products.
8. Smoking or use of recreational drugs.
9. Alcohol intake exceeding 2 standard units per (e.g. \>1 standard drink).
10. Pregnant or planning to conceive during the trial.
11. High habitual caffeine intake (\>400 mg/day)
12. Recent participation in another clinical trial involving dietary or exercise interventions (\<6 months).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT07135232
Study Brief:
Protocol Section:
NCT07135232