Investigation of the Influence of Careless™, a Mangifera... | NCT02511899

NCT02511899

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mango fruit powder 100mg	Active Comparator	Mango fruit powder 100mg	Dietary Supplement: Mango fruit powder
Mango fruit powder 300mg	Active Comparator	Mango fruit powder 300mg	Dietary Supplement: Mango fruit powder

Name	Type	Description	Arm Group Labels	Other Names
Mango fruit powder	Dietary Supplement	Dietary supplement; Mango fruit powder	Mango fruit powder 100mg Mango fruit powder 300mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology	Change over time for microcirculation	baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake
Delta change of endothelial function using EndoPAT™ (baseline and 3hour post)	Changes over time of endothelial function	baseline before intake at the same day and 3 hours post intake

Measure	Description	Time Frame
Tolerability, number of participants with adverse events		after 6 hours of intake

Eligibility Module

Eligibility Criteria

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