Clinical trial NCT02635594: Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Recovery
Endothelial Function
Lead sponsor: Lonza Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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

Primary outcomes:
measure: postprandial endothelial function
timeFrame: after 4 weeks supplementation
Secondary outcomes:
measure: Maximal strength (Nm) before and after exhaustive exercise
timeFrame: immediately before, 0h, 2h, 24h, 48h,
measure: pain before and after exhaustive exercise (VAS)
timeFrame: immediately before, 0h, 2h, 24h, 48h,
measure: Creatin Kinase (CK) before and after exhaustive exercise
timeFrame: immediately before, 0h, 2h, 24h, 48h,
measure: Myoglobine (Mb) before and after exhaustive exercise
timeFrame: immediately before, 0h, 2h, 24h, 48h,
measure: Biomarker for vascular health
timeFrame: after 4 weeks supplementation
Other outcomes:
measure: Adverse Events
timeFrame: after 4 weeks supplementation
measure: Blood routine parameters
timeFrame: at screening and after 4 weeks supplementation
measure: Tolerability (questionnaire)
timeFrame: after 4 weeks supplementation
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
state: Baden-Württemberg
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: