Effects of L-lysine on Adrenal Secretion (L-Lysine)
Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.
Sponsor: University Hospital, Rouen
This observational or N/A phase trial investigates Healthy Volunteers and Male and is currently completed. University Hospital, Rouen leads this study, which shows 6 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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
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
Status Flow
Change History
6 versions recorded-
Apr 17, 2026 — Present [daily]
Completed
Phase: NA → None
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Sep 2024 — Apr 2026 [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jan 2021 — Jul 2024 [monthly]
Completed NA
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Jun 2018 — Jan 2021 [monthly]
Completed NA
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed NA
First recorded
Oct 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- University Hospital, Rouen
For direct contact, visit the study record on ClinicalTrials.gov .