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Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carnipure® tartrate | Experimental | 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate |
|
| Placebo | Placebo Comparator | 1000mg cellulose + 475mg L-tartaric acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Carnitine | Dietary Supplement | 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| postprandial endothelial function | postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal strength (Nm) before and after exhaustive exercise | Maxiaml strength assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after) | immediately before, 0h, 2h, 24h, 48h, |
| pain before and after exhaustive exercise (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events assessed after 4 weeks supplementation with verum and placebo | after 4 weeks supplementation |
| Blood routine parameters | Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters assessed at screening and after 4 weeks supplementation with verum and placebo |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, PhD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | Baden-Wurttemberg | 73728 | Germany |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Other | 1000mg cellulose + 475mg L-tartaric acid |
|
Pain assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after) |
| immediately before, 0h, 2h, 24h, 48h, |
| Creatin Kinase (CK) before and after exhaustive exercise | Assessement of CK after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after) | immediately before, 0h, 2h, 24h, 48h, |
| Myoglobine (Mb) before and after exhaustive exercise | Assessement of Mb after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after) | immediately before, 0h, 2h, 24h, 48h, |
| Biomarker for vascular health | Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation |
| at screening and after 4 weeks supplementation |
| Tolerability (questionnaire) | Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation |