Official Title
Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
Phase
N/ALead Sponsor
Vital SolutionsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Metabolism Microcirculation Cardiovascular DiseaseIntervention/Treatment
mango ...Study Participants
10Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
Dietary supplement; Mango fruit powder
Mango fruit powder 100mg
Mango fruit powder 300mg
Inclusion Criteria: Subject is able and willing to sign the Informed Consent Form prior to screening evaluations Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology Healthy normal skin condition at the forearm BMI: 19-30 kg/m2 Female Age ≥ 40 and ≤ 70 years 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, L-Arginine, Niacin, medication of haemodilution, blood flow stimulating products like Aspirin) potentially interfering with this study at screening For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening Atopic dermatitis or affected skin at the forearm Regular consumption of caffeine > 275 mg (equivalent to 3-4 cups of coffee or 9 cups of black tea) 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 since this may also influence the results Subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caffeine the day prior to visit 1 and 2 Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to and during visit 1 and 2 Sunbathing or the use of sun-beds 2 weeks prior to study days Injury on the finger, influencing the EndoPAT™ measurement 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 product 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