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CompletedNCT02588313Updated Sep 23, 2016

Investigation of Long-term Effects of CarelessTM on Microcirculation

An interventional study of Mango fruit powder in Disorder of Circulatory System and Metabolic Disease, sponsored by Vital Solutions Swiss AG. Completed at 1 site in Germany. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-23.

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

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects will be investigated with 100mg and 300mg CarelessTM and compared to placebo.

Read the detailed description

Aim of the study is to investigate long-term effects of CarelessTM, a Mangifera indica fruit powder on microcirculation and endothelial function after supplementation of 4 weeks. Effects will be investigated with 100mg and 300mg CarelessTM and compared to placebo.

To describe targeted parameter, cutaneous microcirculation will be measured at 1 mm depth as well as flow mediated endothelial function at the beginning and end of supplementation, each. Furthermore, the parameters will be determined postprandially 1 hour after glucose loading. Additionally the influence on the glucose metabolism, as well as on body weight and body fat will be documented.

02

Conditions studied

  • Disorder of Circulatory System
  • Metabolic Disease

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03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 75 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic 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
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers
  • Men and postmenopausal women
  • HOMA Index ≥2 and \<5
  • BMI: 19 - 30 kg/m2
  • Age ≥ 40 and ≤ 70 years
  • Nonsmoker
  • Written consent to participate in the study
  • 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 sup-plements (e.g. polyphenols, L-Arginine, Niacin, medication of haemodilution, blood flow stimu-lating products like Aspirin (Acetylsalicylsäure), Clopidogrel (Adenosin-Diphosphat(ADP)-Inhibitors), Glykoprotein-IIb/IIIa-Inhibitors, Heparin, Marcumar (Vitamin K antagonists); Dabiga-tran (Faktor IIa synthese Inhibitors) Rivaroxaban (Faktor Xa Antagonist), Statins) potentially in-terfering with this study at screening.
  • For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
  • Diabetes
  • Atopic dermatitis or affected skin at the forearm
  • Injury on the finger, influencing the EndoPATTM measurement
  • 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 during the study.
  • Subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caf-feine 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
  • 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 preparation or to single ingredients
  • Pregnant subject or subject planning to become pregnant during the study; breast-feeding sub-ject.
  • 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
75 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

  • Placebo comparator
    Placebo formulation

    Placebo formulation

    Dietary Supplement: Mango fruit powder

Interventions

  • Dietary supplementMango fruit powder

    Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design

    Also known as: CarelessTM

06

What researchers measure

Primary outcomes

  1. Measurement of circulation

    Measurement of dermal microcirculation using "O2C, Lea Technik": * Relative peripheral blood flow (LDF) * Venous oxygen saturation (SO2 ven) * Relative amount of haemoglobin (rHb). Delta change of dermal microcirculation from baseline to end of supplementation is investigated. Addi-tionally, the delta change of dermal microcirculation from baseline to end of supplementation post-prandial is determined, which means the evaluation of postprandial effects on reactive hyperaemia index after glucose load.

    Time frame: Baseline at day 1 and after 4 weeks supplementation

Secondary outcomes

  1. Measurement of glucose related biomarker

    Measurement of Biomarker HOMA-Index, HbA1c at baseline and end of supplementation under fasting conditions.

    Time frame: Baseline at day 1 and after 4 weeks supplementation

  2. Questionnaire on fatigue and vigor

    Questionnaire on fatigue and vigor

    Time frame: Baseline at day 1 and after 4 weeks supplementation

  3. Monitoring of adverse effects

    Reporting of adverse effects to evaluate tolerability

    Time frame: During study execution over 4 weeks

  4. Measurement of endothelial function using "EndoPATTM, Itamar"

    Measurement of endothelial function using "EndoPATTM, Itamar" * Reactive hyperaemia index (RHI and lnRHI) * Arterial stiffness (AI75) Delta change of endothelial function and arterial stiffness from baseline to end of supplementation is investigated. Additionally, the delta change of endothelial function from baseline to end of supplemen-tation postprandial is determined, which means the evaluation of postprandial effects on relative hy-peraemia index after glucose load.

    Time frame: Baseline at day 1 and after 4 weeks supplementation

  5. Measurement of ox LDL

    Measurement of ox LDL

    Time frame: Baseline at day 1 and after 4 weeks supplementation

Other outcomes

  1. Body composition

    Body weight and body fat (Body impedance analysis) determination

    Time frame: Baseline at day 1 and after 4 weeks supplementation

  2. Blood glucose

    Capillary blood glucose

    Time frame: Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading

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 Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02588313
Lead sponsor
Vital Solutions Swiss AG
Responsible party
Sponsor
First posted
Oct 27, 2015
Start date
Oct 2015
Primary completion
Aug 2016
Completion
Sep 2016
Last update
Sep 23, 2016

Study contacts

Claudia Reule, PhD
study chair · BioTeSys GmbH

Oversight

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

Not currently enrolling

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

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