Table 1 In- and exclusion criteria
Inclusion criteria | Exclusion criteria |
|---|---|
Subject is able and willing to sign the Informed Consent Form prior to screening evaluations | Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or antioxidative drugs or supplements, antihypertensive drugs) potentially interfering with this study at screening |
Healthy subjects: Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology | For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening |
Men and women | Diabetes or serious cardiovascular diseases |
Age ≥ 22 and ≤50 years | 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) |
BMI: 19–30 kg/m2 | Diet high in vegetables and fruits ≥ 5 portions per day |
Physically active 1–3 times per week | Participants anticipating a change in their lifestyle or physical activity levels during the study |
Nonsmoker | Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 h prior to visit 2 until visit 5 |
Able and willing to follow the study protocol procedures | 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-feeding subject | |
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 |