Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function

Vital Solutions Swiss

Status

Completed

Conditions

Metabolism

Microcirculation

Cardiovascular Disease

Treatments

Dietary Supplement: Mango fruit powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT02511899

BTS850/15

Details and patient eligibility

About

Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.

Enrollment

10 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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