Status:
COMPLETED
Effects of L-lysine on Adrenal Secretion
Lead Sponsor:
University Hospital, Rouen
Conditions:
Male
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
Data from the literature and previous in vitro research conducted in the investigators' laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid secretion might be cont...
Detailed Description
STUDY DESIGN Proof of concept, interventional, monocentric, randomised, double blind, cross-over study: The effects of L-lysine on corticosteroid secretion will be compared to those of a placebo. STUD...
Eligibility Criteria
Inclusion
- Male subjects;
- Age ranging 18 - 45 years old;
- Submitted to a social security regimen;
- Agreeing to the study \& Informed consent form signed;
- Body mass index (\[weight (kg)/height (m)\]²) \< 27;
- No treatment received 6 weeks before inclusion;
- No anomaly after: complete clinical examination, pulse measurement, ECG;
- Blood pressure on AMBP : Mean systolic blood pressure \< 135 mmHg \& Mean diastolic blood pressure \< 85 mmHg
- No biological abnormality after biological testing o No participation in a clinical trial 3 months before inclusion.
Exclusion
- Subject not agreeing to the study or impossible to follow-up;
- Known history of significant medical or surgical pathology, notably endocrine;
- Renal or hepatic insufficiency;
- Nephrotic syndrome;
- Edematous syndrome;
- Hypertension or postural hypotension;
- Cardiac rhythm or conduction pathologies;
- Cardiac insufficiency;
- Epilepsy;
- Significant psychiatric disorder;
- Known history of severe allergy, hypersensitivity to metoclopramide;
- Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficit;
- Impaired lactose tolerance.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01220388
Start Date
October 1 2010
End Date
March 1 2013
Last Update
June 18 2013
Active Locations (1)
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1
Rouen Clinical research Centre (CIC 0204)
Rouen, France, 76031