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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02635594
Other study ID # BTS884/15
Secondary ID
Status Completed
Phase N/A
First received December 10, 2015
Last updated September 6, 2016
Start date December 2015
Est. completion date June 2016

Study information

Verified date September 2016
Source Lonza Ltd.
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L-Carnitine
1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
Other:
Placebo
1000mg cellulose + 475mg L-tartaric acid

Locations

Country Name City State
Germany BioTeSys GmbH Esslingen Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
Lonza Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

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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