CClinicalTrials.gg
CompletedNCT02511899Updated Aug 7, 2015

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

An interventional study of Mango fruit powder in Microcirculation, Metabolism and Cardiovascular Disease, sponsored by Vital Solutions Swiss AG. Completed at 1 site in Germany. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-07.

Sponsored by Vital Solutions Swiss AG · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Microcirculation
  • Metabolism
  • Cardiovascular Disease

Keywords

  • Microcirculation
  • Endothelial function
  • Metabolism
  • Cardiovascular Disease
  • human study
  • healthy subjects
  • Mangifera indica
  • Careless
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 10 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Vital Solutions Swiss AG is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Mango fruit powder 100mg

    Mango fruit powder 100mg

    Dietary Supplement: Mango fruit powder

  • Active comparator
    Mango fruit powder 300mg

    Mango fruit powder 300mg

    Dietary Supplement: Mango fruit powder

Interventions

  • Dietary supplementMango fruit powder

    Dietary supplement; Mango fruit powder

    Also known as: Careless

06

What researchers measure

Primary outcomes

  1. 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

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

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

    Changes over time of endothelial function

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

Secondary outcomes

  1. Tolerability, number of participants with adverse events

    Time frame: after 6 hours of intake

07

Study locations

1 site
  • BioTeSys GmbH
    Esslingen, 73728, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02511899
Lead sponsor
Vital Solutions Swiss AG
Responsible party
Sponsor
First posted
Jul 30, 2015
Start date
May 2015
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 7, 2015

Study contacts

Claudia Reule, PhD
study director · BioTeSys GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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