Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
Not Applicable
Completed
- Conditions
- MicrocirculationMetabolismCardiovascular Disease
- Interventions
- Dietary Supplement: Mango fruit powder
- Registration Number
- NCT02511899
- Lead Sponsor
- Vital Solutions Swiss AG
- Brief Summary
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mango fruit powder 100mg Mango fruit powder Mango fruit powder 100mg Mango fruit powder 300mg Mango fruit powder Mango fruit powder 300mg
- Primary Outcome Measures
Name Time Method Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake Change over time for microcirculation
Delta change of endothelial function using EndoPAT™ (baseline and 3hour post) baseline before intake at the same day and 3 hours post intake Changes over time of endothelial function
- Secondary Outcome Measures
Name Time Method Tolerability, number of participants with adverse events after 6 hours of intake
Trial Locations
- Locations (1)
BioTeSys GmbH
🇩🇪Esslingen, Germany