Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635594
• Other study ID #: BTS884/15
• 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

• Endothelial Function
• Healthy Volunteers
• Recovery

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