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

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

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

Conditions
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Microcirculation, Metabolism, Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: Mango fruit powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mango fruit powder 100mg<br>Mango fruit powder 100mg | Dietary Supplement: Mango fruit powder<br>* Dietary supplement; Mango fruit powder<br>* Other names: Careless;|
| Active Comparator: Mango fruit powder 300mg<br>Mango fruit powder 300mg | Dietary Supplement: Mango fruit powder<br>* Dietary supplement; Mango fruit powder<br>* Other names: Careless;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microcirculation, Endothelial function, Metabolism, Cardiovascular Disease, human study, healthy subjects, Mangifera indica, Careless