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

Sponsor

Vital Solutions Swiss AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02511899

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Microcirculation Metabolism Cardiovascular Disease	Dietary Supplement: Mango fruit powder	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mango fruit powder 100mg Mango fruit powder 100mg	Dietary Supplement: Mango fruit powder Dietary supplement; Mango fruit powder Other Names: Careless
Active Comparator: Mango fruit powder 300mg Mango fruit powder 300mg	Dietary Supplement: Mango fruit powder Dietary supplement; Mango fruit powder Other Names: Careless

Arm

Intervention/Treatment

Active Comparator: Mango fruit powder 100mg

Mango fruit powder 100mg

Dietary Supplement: Mango fruit powder

Dietary supplement; Mango fruit powder

Other Names:

Careless

Active Comparator: Mango fruit powder 300mg

Mango fruit powder 300mg

Dietary Supplement: Mango fruit powder

Dietary supplement; Mango fruit powder

Other Names:

Careless

Outcome Measures

Primary Outcome Measures

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

Tolerability, number of participants with adverse events [after 6 hours of intake]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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