Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers Recovery Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carnipure® tartrate

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

Group Type EXPERIMENTAL

L-Carnitine

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

1000mg cellulose + 475mg L-tartaric acid

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1000mg cellulose + 475mg L-tartaric acid

Interventions

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L-Carnitine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

1000mg cellulose + 475mg L-tartaric acid

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes