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

NCT02511899 | Completed

• 1 other identifier: BTS850/15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Microcirculation; Endothelial function; Metabolism; Cardiovascular Disease; human study; healthy subjects; Mangifera indica; Careless

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Tolerability, number of participants with adverse events

  after 6 hours of intake

Study Arms (2)

Mango fruit powder 100mg

ACTIVE COMPARATOR

Mango fruit powder 100mg

Dietary Supplement: Mango fruit powder

Mango fruit powder 300mg

ACTIVE COMPARATOR

Mango fruit powder 300mg

Dietary Supplement: Mango fruit powder

Interventions

Mango fruit powder DIETARY_SUPPLEMENT

Dietary supplement; Mango fruit powder

Also known as: Careless

Mango fruit powder 100mg; Mango fruit powder 300mg

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital Solutions Swiss AG: lead

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Claudia Reule, PhD

  BioTeSys GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 30, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

DE (1)