Healthy Volunteers Clinical Trial
Official title:
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
Verified date | September 2016 |
Source | Lonza Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Germany | BioTeSys GmbH | Esslingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Lonza Ltd. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Adverse events assessed after 4 weeks supplementation with verum and placebo | after 4 weeks supplementation | Yes |
Other | 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 | at screening and after 4 weeks supplementation | Yes |
Other | Tolerability (questionnaire) | Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation | Yes |
Primary | postprandial endothelial function | postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation | No |
Secondary | 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, | No |
Secondary | 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, | No |
Secondary | 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, | No |
Secondary | 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, | No |
Secondary | Biomarker for vascular health | Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo | after 4 weeks supplementation | No |
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