Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Recovery; Endothelial Function
• Intervention / Treatment: Dietary supplement: L-Carnitine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Esslingen, Baden-Württemberg, Germany, 73728
      • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carnipure® tartrate; 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate	Dietary supplement: L-Carnitine; 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
Placebo Comparator: Placebo; 1000mg cellulose + 475mg L-tartaric acid	Other: Placebo; 1000mg cellulose + 475mg L-tartaric acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postprandial endothelial function	postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo	after 4 weeks supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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,
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,
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,
Biomarker for vascular health	Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo	after 4 weeks supplementation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events assessed after 4 weeks supplementation with verum and placebo	after 4 weeks supplementation
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
Tolerability (questionnaire)	Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo	after 4 weeks supplementation

Collaborators and Investigators

• Sponsor: Lonza Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BTS884/15