Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

Lonza

Status: Completed

Conditions: Endothelial Function; Healthy Volunteers; Recovery

Treatments: Dietary Supplement: L-Carnitine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02635594

BTS884/15

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 2 patient groups, including a placebo group

Carnipure® tartrate

Experimental group

Description:

1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate

Treatment:

Dietary Supplement: L-Carnitine

Placebo

Placebo Comparator group

Description:

1000mg cellulose + 475mg L-tartaric acid

Treatment:

Other: Placebo