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

NCT ID: NCT02511899

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

Brief Summary

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

Conditions

Microcirculation; Metabolism; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Mango fruit powder 100mg

Mango fruit powder 100mg

Group Type: ACTIVE_COMPARATOR

Mango fruit powder

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement; Mango fruit powder

Mango fruit powder 300mg

Mango fruit powder 300mg

Group Type: ACTIVE_COMPARATOR

Mango fruit powder

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement; Mango fruit powder

Interventions

Mango fruit powder

Dietary supplement; Mango fruit powder

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Careless

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vital Solutions Swiss AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Reule, PhD

Role: STUDY_DIRECTOR

BioTeSys GmbH

Locations

BioTeSys GmbH

Esslingen am Neckar, , Germany

Countries

Germany

Other Identifiers

BTS850/15

Identifier Type: -

Identifier Source: org_study_id