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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mango fruit powder 100mg | Active Comparator | Mango fruit powder 100mg |
|
| Mango fruit powder 300mg | Active Comparator | Mango fruit powder 300mg |
|
| Placebo formulation | Placebo Comparator | Placebo formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mango fruit powder | Dietary Supplement | Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of circulation | Measurement of dermal microcirculation using "O2C, Lea Technik":
| Baseline at day 1 and after 4 weeks supplementation |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body weight and body fat (Body impedance analysis) determination | Baseline at day 1 and after 4 weeks supplementation |
| Blood glucose | Capillary blood glucose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Reule, PhD | BioTeSys GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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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"
| 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 |
| Baseline at day 1 and after 4 weeks supplementation, before 1h and 2h after glucose loading |