Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

Study Overview
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Brief Summary
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Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.

Official Title
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Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery From Physical Exertion in Healthy People - a Randomized, Double-blind, Placebo-controlled, Two-way Cross-over Study

Conditions
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Healthy Volunteers, Recovery, Endothelial Function

Intervention / Treatment
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* Dietary Supplement: L-Carnitine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women between 25 and 45 years Body mass index (BMI) between 20 and 30 kg/m² Non-smoker Physically active 1-2 times per week Exclusion Criteria: Competitive athlete or performance of high intensity training Vegan Nutrition with high portion of meat (> 3 times meat per week). Injury at the finger History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.) Known allergy to ingredients of study preparation Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome) Hypo/ hypertension or taking anti hypo/ hypertension medication Untreated thyroid dysfunction Atherosclerosis or other relevant musculoskeletal diseases/ injuries Anemia (women: Hb <11 g/ dl; men: 12.5 g/ dl) Eating disorder Present or recent use of drugs and dietary supplements that affect the endothelial function, re-covery or lipid status 2 months before or during the study (e.g. L-Carnitine, Arginine, omega3 FA, polyphenol rich supplements (e.g. OPC, cacao, etc) antihypertensive drugs, anti hyperlipidemic drugs, regular intake of protein-shakes etc.) Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b. Female patients that are pregnant or nursing Night shift worker Donation of blood or similar blood loss within the previous 30 days before screening; Participation in a clinical trial with an investigational product within 30 days before screening Known alcohol abuse or drug abuse Known infection of human immunodeficiency virus (HIV) or hepatitis B or C Known lactose intolerance, dairy protein allergy or allergy to nuts

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnipure® tartrate<br>1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate | Dietary Supplement: L-Carnitine<br>* 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate<br>|
| Placebo Comparator: Placebo<br>1000mg cellulose + 475mg L-tartaric acid | Other: Placebo<br>* 1000mg cellulose + 475mg L-tartaric acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |