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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511899
• Other study ID #: BTS850/15
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: August 6, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Vital Solutions Swiss AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolism
• Microcirculation

Intervention

Dietary Supplement:
• Mango fruit powder
Dietary supplement; Mango fruit powder

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Vital Solutions Swiss AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Tolerability, number of participants with adverse events		after 6 hours of intake	Yes