Effects of L-lysine on Adrenal Secretion
Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Male; Healthy Volunteers
Intervention: L-lysine (Dietary Supplement); placebo (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: University Hospital, Rouen Official(s) and/or principal investigator(s): Hervé Lefebvre, PHD, Principal Investigator, Affiliation: Rouen University Hospital
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 controlled by a paracrine mechanism involving serotonin type IV receptor
(5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as
well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels
will be measured under treatment with aprepitant versus placebo, in both basal conditions
and after activation of the adrenocortical function by various stimuli, including upright
posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be
given two substances (L-lysine and placebo) in a random order during two 13 days periods
separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4
receptors in the control of corticosteroid production in normal man.
Clinical Details
Official title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Plasma aldosterone variation during orthostatic test
Secondary outcome: Basal aldosterone alteration; Aldosterone variation during metoclopramide & salt-free diet tests; Basal and stimulated (3 different tests) alterations of renin, cortisol & ACTH
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. STUDY OBJECTIVES Main objective: to verify that adrenal corticosteroid
secretion is actually controlled by L-lysine. Secondary objective: to determine the
physiological conditions that involve the control of adrenocortical function by t5-HT4
receptors. NUMBER OF SUBJECTS 20 healthy volunteers ELIGIBILITY CRITERIA (see below)
DURATION OF STUDY Overall duration: 13 months Inclusion period: 12 months Follow up period
(for 1 subject): 5 weeks Exclusion period: 1 month ENDPOINTS PRIMARY ENDPOINT: blood
aldosterone variation during orthostatic test SECONDARY ENDPOINTS Basal aldosterone
alteration Aldosterone variation during metoclopramide & salt-free diet tests Basal and
stimulated (3 different tests) alterations of renin, cortisol & ACTH REGULATORY
AUTHORIZATIONS Ethics committee authorization: jan 21,2010 Regulatory authorization: july
9th 2010
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Rouen Clinical research Centre (CIC 0204), Rouen 76031, France
Additional Information
Starting date: October 2010
Last updated: June 17, 2013
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