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OpenTrials
Completed

NCT Number: NCT02635594

Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery

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

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Competitive athlete or performance of high intensity training
  • Vegan
  • Nutrition with high portion of meat (> 3 times meat per week).
  • Injury at the finger
  • History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.)
  • Known allergy to ingredients of study preparation
  • Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome)
  • Hypo/ hypertension or taking anti hypo/ hypertension medication
  • Untreated thyroid dysfunction
  • Atherosclerosis or other relevant musculoskeletal diseases/ injuries
  • Anemia (women: Hb <11 g/ dl; men: 12.5 g/ dl)
  • Eating disorder
  • 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.)
  • Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b.
  • Female patients that are pregnant or nursing
  • Night shift worker
  • Donation of blood or similar blood loss within the previous 30 days before screening;
  • Participation in a clinical trial with an investigational product within 30 days before screening
  • Known alcohol abuse or drug abuse
  • Known infection of human immunodeficiency virus (HIV) or hepatitis B or C
  • Known lactose intolerance, dairy protein allergy or allergy to nuts

Treatment and study plan

L-carnitine

Dietary Supplement

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

Placebo

Other

1000mg cellulose + 475mg L-tartaric acid

Primary outcomes

  1. postprandial endothelial function

    Time frame: after 4 weeks supplementation

    postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo

Secondary outcomes

  1. Maximal strength (Nm) before and after exhaustive exercise

    Time frame: immediately before, 0h, 2h, 24h, 48h,

    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)

  2. pain before and after exhaustive exercise (VAS)

    Time frame: immediately before, 0h, 2h, 24h, 48h,

    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)

  3. Creatin Kinase (CK) before and after exhaustive exercise

    Time frame: immediately before, 0h, 2h, 24h, 48h,

    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)

  4. Myoglobine (Mb) before and after exhaustive exercise

    Time frame: immediately before, 0h, 2h, 24h, 48h,

    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)

  5. Biomarker for vascular health

    Time frame: after 4 weeks supplementation

    Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo

Other outcomes

  1. Adverse Events

    Time frame: after 4 weeks supplementation

    Adverse events assessed after 4 weeks supplementation with verum and placebo

  2. Blood routine parameters

    Time frame: at screening and after 4 weeks supplementation

    Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters assessed at screening and after 4 weeks supplementation with verum and placebo

  3. Tolerability (questionnaire)

    Time frame: after 4 weeks supplementation

    Tolerability assessed after 4 weeks supplementation with verum in comparison to placebo

Sponsors and collaborators

Lead sponsor

Lonza Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2015
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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