Effects of L-lysine on Adrenal Secretion

Healthy Volunteers Clinical Trial

— L-Lysine  

Official title:

Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220388
• Other study ID #: 2008/138/HP
• Status: Completed
• Phase: N/A
• First received: October 11, 2010
• Last updated: June 17, 2013
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers
• Male

Intervention

Dietary Supplement:
• L-lysine
L-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals
• placebo
placebo, 3 times a day, orally, during meals

Locations

Country	Name	City	State
France	Rouen Clinical research Centre (CIC 0204)	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma aldosterone variation during orthostatic test		Day 5 of treatment, at each period	No
Secondary	Basal aldosterone alteration; Aldosterone variation during metoclopramide & salt-free diet tests; Basal and stimulated (3 different tests) alterations of renin, cortisol & ACTH		Day 5, 6, 7 and 11 of treatment, at each period	No