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Investigation of Long-term Effects of CarelessTM on Microcirculation

Primary Purpose

Disorder of Circulatory System, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mango fruit powder
Sponsored by
Vital Solutions Swiss AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disorder of Circulatory System

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • BioTeSys GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Mango fruit powder 100mg

Mango fruit powder 300mg

Placebo formulation

Arm Description

Mango fruit powder 100mg

Mango fruit powder 300mg

Placebo formulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measurement of glucose related biomarker
Measurement of Biomarker HOMA-Index, HbA1c at baseline and end of supplementation under fasting conditions.
Questionnaire on fatigue and vigor
Questionnaire on fatigue and vigor
Monitoring of adverse effects
Reporting of adverse effects to evaluate tolerability
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.
Measurement of ox LDL
Measurement of ox LDL

Full Information

First Posted
October 23, 2015
Last Updated
September 22, 2016
Sponsor
Vital Solutions Swiss AG
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1. Study Identification

Unique Protocol Identification Number
NCT02588313
Brief Title
Investigation of Long-term Effects of CarelessTM on Microcirculation
Official Title
Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vital Solutions Swiss AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Circulatory System, Metabolic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mango fruit powder 100mg
Arm Type
Active Comparator
Arm Description
Mango fruit powder 100mg
Arm Title
Mango fruit powder 300mg
Arm Type
Active Comparator
Arm Description
Mango fruit powder 300mg
Arm Title
Placebo formulation
Arm Type
Placebo Comparator
Arm Description
Placebo formulation
Intervention Type
Dietary Supplement
Intervention Name(s)
Mango fruit powder
Other Intervention Name(s)
CarelessTM
Intervention Description
Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design
Primary Outcome Measure Information:
Title
Measurement of circulation
Description
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 Outcome Measure Information:
Title
Measurement of glucose related biomarker
Description
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
Title
Questionnaire on fatigue and vigor
Description
Questionnaire on fatigue and vigor
Time Frame
Baseline at day 1 and after 4 weeks supplementation
Title
Monitoring of adverse effects
Description
Reporting of adverse effects to evaluate tolerability
Time Frame
During study execution over 4 weeks
Title
Measurement of endothelial function using "EndoPATTM, Itamar"
Description
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
Title
Measurement of ox LDL
Description
Measurement of ox LDL
Time Frame
Baseline at day 1 and after 4 weeks supplementation
Other Pre-specified Outcome Measures:
Title
Body composition
Description
Body weight and body fat (Body impedance analysis) determination
Time Frame
Baseline at day 1 and after 4 weeks supplementation
Title
Blood glucose
Description
Capillary blood glucose
Time Frame
Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Reule, PhD
Organizational Affiliation
BioTeSys GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
BioTeSys GmbH
City
Esslingen
ZIP/Postal Code
73728
Country
Germany

12. IPD Sharing Statement

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Investigation of Long-term Effects of CarelessTM on Microcirculation

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