Clinical trial NCT02511899: Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
Official title: Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Metabolism
Cardiovascular Disease
Keywords: Microcirculation
Endothelial function
Metabolism
Cardiovascular Disease
human study
healthy subjects
Mangifera indica
Careless
Lead sponsor: Vital Solutions Swiss AG
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology
timeFrame: baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake
measure: Delta change of endothelial function using EndoPAT™ (baseline and 3hour post)
timeFrame: baseline before intake at the same day and 3 hours post intake
Secondary outcomes:
measure: Tolerability, number of participants with adverse events
timeFrame: after 6 hours of intake
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Claudia Reule, PhD
role: STUDY_DIRECTOR
References: