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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02923102
Eligibility Criteria:
Inclusion Criteria:
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Health volunteers: Subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
* Men and women
* Age ≥ 22 and ≤ 50 years
* BMI: 19-30 kg/m2
* Physically active 1-3 times per week
* Nonsmoker
* Able and willing to follow the study protocol procedures
Exclusion Criteria:
* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening.
* For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
* Diabetes or serious cardiovascular diseases
* Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
* Diet high in vegetables and fruits ≥ 5 portions per day
* Participants anticipating a change in their lifestyle or physical activity levels during the study.
* Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to visit 2 until visit 5.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
* Known hypersensitivity to the study preparation or to single ingredients
* Pregnant subject or subject planning to become pregnant during the study; breast-
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 4 weeks prior to visit 1 or during the study.
* Subject involved in any clinical or food study within the preceding month
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
50 Years
Study:
NCT02923102
Study Brief:
Protocol Section:
NCT02923102