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OpenTrials
Completed

NCT Number: NCT02511899

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mango fruit powder

Dietary Supplement

Dietary supplement; Mango fruit powder

Other names: Careless

Primary outcomes

  1. Delta change of dermal microcirculation before and after intake (1h, 2h, 3h, 4h and 6h post) measured by O2C technology

    Time frame: baseline before intake at the same day and 1hour, 2hour, 3hour, 4hour and 6hour post intake

    Change over time for microcirculation

  2. Delta change of endothelial function using EndoPAT™ (baseline and 3hour post)

    Time frame: baseline before intake at the same day and 3 hours post intake

    Changes over time of endothelial function

Secondary outcomes

  1. Tolerability, number of participants with adverse events

    Time frame: after 6 hours of intake

Sponsors and collaborators

Lead sponsor

Vital Solutions Swiss AG

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2015
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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