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Effects of L-lysine on Adrenal Secretion (L-Lysine)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Hospital, Rouen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01220388
First received: October 11, 2010
Last updated: October 12, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Male
Healthy Volunteers
 Dietary Supplement: L-lysine
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Plasma aldosterone variation during orthostatic test [ Time Frame: Day 5 of treatment, at each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Basal aldosterone alteration; Aldosterone variation during metoclopramide & salt-free diet tests; Basal and stimulated (3 different tests) alterations of renin, cortisol & ACTH [ Time Frame: Day 5, 6, 7 and 11 of treatment, at each period ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-lysine
11 days treatment with study drug, order of periods (active treatment or placebo) being sorted out.
 Dietary Supplement: L-lysine
L-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals
Placebo Comparator: placebo
11 days treatment with study drug, order of periods (L-lysine or placebo) being sorted out.
 Dietary Supplement: placebo
placebo, 3 times a day, orally, during meals

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220388

Contacts
Contact: Hervé Lefebvre, PHD 00 33 2 88 89 90 ext 6 90 81 Herve.Lefbvre@chu-rouen.fr
Contact: Anne F Cailleux, MD 00 33 2 88 89 90 ext 9 88 62 Anne.Cailleux@chu-rouen.fr

Locations
France
Rouen Clinical research Centre (CIC 0204) Not yet recruiting
Rouen, France, 76031
Contact: Anne F Cailleux, MD     02 32 88 89 90 ext 6 88 62     Anne.Cailleux@chu-rouen.fr    
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Hervé Lefebvre, PHD Rouen University Hospital
  More Information

No publications provided

Responsible Party: Mr Teillard, Rouen University Hospital
ClinicalTrials.gov Identifier: NCT01220388     History of Changes
Other Study ID Numbers: 2008/138/HP
Study First Received: October 11, 2010
Last Updated: October 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Aldosterone
L-lysine
Cortisol
Adrenal glands

ClinicalTrials.gov processed this record on May 19, 2013