NCT02635594

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

December 10, 2015

Last Update Submit

September 6, 2016

Conditions

Healthy VolunteersRecoveryEndothelial Function

Outcome Measures

Primary Outcomes (1)

  • postprandial endothelial function

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

    after 4 weeks supplementation

Secondary Outcomes (5)

  • Maximal strength (Nm) before and after exhaustive exercise

    immediately before, 0h, 2h, 24h, 48h,

  • pain before and after exhaustive exercise (VAS)

    immediately before, 0h, 2h, 24h, 48h,

  • Creatin Kinase (CK) before and after exhaustive exercise

    immediately before, 0h, 2h, 24h, 48h,

  • Myoglobine (Mb) before and after exhaustive exercise

    immediately before, 0h, 2h, 24h, 48h,

  • Biomarker for vascular health

    after 4 weeks supplementation

Other Outcomes (3)

  • Adverse Events

    after 4 weeks supplementation

  • Blood routine parameters

    at screening and after 4 weeks supplementation

  • Tolerability (questionnaire)

    after 4 weeks supplementation

Study Arms (2)

Carnipure® tartrate

EXPERIMENTAL

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

Dietary Supplement: L-Carnitine

Placebo

PLACEBO COMPARATOR

1000mg cellulose + 475mg L-tartaric acid

Other: Placebo

Interventions

L-CarnitineDIETARY_SUPPLEMENT

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

Carnipure® tartrate
PlaceboOTHER

1000mg cellulose + 475mg L-tartaric acid

Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Location

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Daniel Menzel, PhD

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 21, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

DE(1)