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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Metabolism; Microcirculation
• Intervention / Treatment: Dietary supplement: Mango fruit powder

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vital Solutions Swiss AG
• Investigators: Study Director: Claudia Reule, PhD, BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Endothelial function; healthy subjects; Metabolism; Microcirculation; Mangifera indica; human study; Careless
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: BTS850/15