NCT01220388

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

October 11, 2010

Last Update Submit

April 13, 2026

Conditions

MaleHealthy Volunteers

Keywords

AldosteroneL-lysineCortisolAdrenal glands

Outcome Measures

Primary Outcomes (1)

  • Plasma aldosterone variation during orthostatic test

    Day 5 of treatment, at each period

Secondary Outcomes (1)

  • 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

Study Arms (2)

L-lysine

EXPERIMENTAL

11 days treatment with study drug, order of periods (active treatment or placebo) being sorted out.

Dietary Supplement: L-lysine

placebo

PLACEBO COMPARATOR

11 days treatment with study drug, order of periods (L-lysine or placebo) being sorted out.

Dietary Supplement: placebo

Interventions

L-lysineDIETARY_SUPPLEMENT

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

L-lysine
placeboDIETARY_SUPPLEMENT

placebo, 3 times a day, orally, during meals

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 anomaly after: complete clinical examination, pulse measurement, ECG;
  • Blood pressure on AMBP : Mean systolic blood pressure \< 135 mmHg \& Mean diastolic blood pressure \< 85 mmHg

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen Clinical research Centre (CIC 0204)

Rouen, 76031, France

Location

Related Publications (1)

  • Duparc C, Andre C, Menard J, Godouet-Getti B, Wils J, Cailleux AF, Moreau-Grange L, Louiset E, Lefebvre H. l-Lysine Acts as a Serotonin Type 4 Receptor Antagonist to Counteract In Vitro and In Vivo the Stimulatory Effect of Serotonergic Agents on Aldosterone Secretion in Man. Horm Metab Res. 2017 Apr;49(4):269-275. doi: 10.1055/s-0042-122781. Epub 2017 Jan 19.

    PMID: 28103616RESULT

MeSH Terms

Interventions

Lysine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Hervé Lefebvre, PHD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(1)