Effect of L-Carnitine on insuline sensitivity

Phase 1

• Conditions: Glucose tolerance; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-000810-31-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Caucasian
•Healthy (as determined by responsible physician based on a medical questionnaire)
•Male
•Age: 18-40 years
•Normal BMI: 18-25 kg/m2
•Stable dietary habits
•No use of medication interfering with investigated study parameters (as determined by responsible physician)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Female
•Haemoglobin levels < 7.8 mmol/L
•Uncontrolled hypertension
•Use of anticoagulants
•Engagement in exercise > 3 hours a week
•Being vegetarian or vegan (because of altered whole body carnitine status)
•Smoking
•Alcohol and/or drug abuse
•Unstable body weight (weight gain or loss > 5kg in the last 3 months)
•Significant food allergies/intolerances (seriously hampering study meals)
•Participation in another biomedical study within 1 month before the first study visit, which would possibly hamper our study results
•Medication use known to hamper subject’s safety during the study procedures
•Medication use known to interfere with investigated study parameters
•Subjects with contra-indications for MRI
•Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the study
•Subjects who do not want to be informed about unexpected medical findings
•Subjects who do not want that their treating physician is informed

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified