Cardiovascular Disease, Metabolism, Microcirculation
Conditions
Keywords
Microcirculation, Endothelial function, Metabolism, Cardiovascular Disease, human study, healthy subjects, Mangifera indica, Careless
Brief summary
Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.
Interventions
DIETARY_SUPPLEMENTMango fruit powder
Dietary supplement; Mango fruit powder
Sponsors
Vital Solutions Swiss AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Tolerability, number of participants with adverse events | after 6 hours of intake |
Countries
Germany
Outcome results
None listed