Investigation of Long-term Effects of CarelessTM on Microcirculation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of Long-term Effects of CarelessTM on Microcirculation in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled Study With Parallel Design

Conditions
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Disorder of Circulatory System, Metabolic Disease

Intervention / Treatment
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* Dietary Supplement: Mango fruit powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mango fruit powder 100mg<br>Mango fruit powder 100mg | Dietary Supplement: Mango fruit powder<br>* Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design<br>* Other names: CarelessTM;|
| Active Comparator: Mango fruit powder 300mg<br>Mango fruit powder 300mg | Dietary Supplement: Mango fruit powder<br>* Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design<br>* Other names: CarelessTM;|
| Placebo Comparator: Placebo formulation<br>Placebo formulation | Dietary Supplement: Mango fruit powder<br>* Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design<br>* Other names: CarelessTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline at day 1 and after 4 weeks supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of glucose related biomarker | Measurement of Biomarker HOMA-Index, HbA1c at baseline and end of supplementation under fasting conditions. | Baseline at day 1 and after 4 weeks supplementation | 
| Questionnaire on fatigue and vigor | Questionnaire on fatigue and vigor | Baseline at day 1 and after 4 weeks supplementation | 
| Monitoring of adverse effects | Reporting of adverse effects to evaluate tolerability | During study execution over 4 weeks | 
| 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. | Baseline at day 1 and after 4 weeks supplementation | 
| Measurement of ox LDL | Measurement of ox LDL | Baseline at day 1 and after 4 weeks supplementation |