Endothelial Function, Healthy Volunteers, Recovery
Conditions
Brief summary
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
Interventions
DIETARY_SUPPLEMENTL-Carnitine
1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
OTHERPlacebo
1000mg cellulose + 475mg L-tartaric acid
Sponsors
Lonza Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
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
1. Competitive athlete or performance of high intensity training 2. Vegan 3. Nutrition with high portion of meat (\> 3 times meat per week). 4. Injury at the finger 5. History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.) 6. Known allergy to ingredients of study preparation 7. Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome) 8. Hypo/ hypertension or taking anti hypo/ hypertension medication 9. Untreated thyroid dysfunction 10. Atherosclerosis or other relevant musculoskeletal diseases/ injuries 11. Anemia (women: Hb \<11 g/ dl; men: 12.5 g/ dl) 12. Eating disorder 13. 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.) 14. Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b. 15. Female patients that are pregnant or nursing 16. Night shift worker 17. Donation of blood or similar blood loss within the previous 30 days before screening; 18. Participation in a clinical trial with an investigational product within 30 days before screening 19. Known alcohol abuse or drug abuse 20. Known infection of human immunodeficiency virus (HIV) or hepatitis B or C 21. Known lactose intolerance, dairy protein allergy or allergy to nuts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postprandial endothelial function | after 4 weeks supplementation | postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain before and after exhaustive exercise (VAS) | immediately before, 0h, 2h, 24h, 48h, | 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) |
| Creatin Kinase (CK) before and after exhaustive exercise | immediately before, 0h, 2h, 24h, 48h, | 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) |
| Myoglobine (Mb) before and after exhaustive exercise | immediately before, 0h, 2h, 24h, 48h, | 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) |
| Biomarker for vascular health | after 4 weeks supplementation | Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo |
| Maximal strength (Nm) before and after exhaustive exercise | immediately before, 0h, 2h, 24h, 48h, | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerability (questionnaire) | after 4 weeks supplementation | Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo |
| Blood routine parameters | at screening and after 4 weeks supplementation | Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters assessed at screening and after 4 weeks supplementation with verum and placebo |
| Adverse Events | after 4 weeks supplementation | Adverse events assessed after 4 weeks supplementation with verum and placebo |
Countries
Germany
Outcome results
None listed