MaleL-LysineNCT01220388
Effects of L-lysine on Adrenal Secretion
A study testing L-lysine in people with Male and Healthy Volunteers, run by University Hospital, Rouen at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male, Healthy Volunteers
- What is being tested?
- L-lysine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.
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.
Read the 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
- Conditions
- Male, Healthy Volunteers
- Being tested
- L-lysine, placebo
- Keywords
- Aldosterone, L-lysine, Cortisol, Adrenal glands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-lysineDietary supplement
L-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals
placeboDietary supplement
placebo, 3 times a day, orally, during meals
| Study group | Role | What they receive |
|---|---|---|
| L-lysine | Experimental | 11 days treatment with study drug, order of periods (active treatment or placebo) being sorted out. Receives: Dietary Supplement: L-lysine |
| placebo | Placebo comparator | 11 days treatment with study drug, order of periods (L-lysine or placebo) being sorted out. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma aldosterone variation during orthostatic test
Measured: 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
Measured: Day 5, 6, 7 and 11 of treatment, at each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MaleStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé Lefebvre, PHD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220388
- Sponsor's protocol ID
- 2008/138/HP
- Acronym
- L-Lysine
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2010
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28103616
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Action L-lysine on Aldosterone and Cortisol Secretion in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01220388
- Acronym / sponsor ID
- L-Lysine / 2008/138/HP
- Conditions
- Male, Healthy Volunteers
- Keywords
- Aldosterone, L-lysine, Cortisol, Adrenal glands
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-lysine | Experimental | Dietary Supplement: L-lysine11 days treatment with study drug, order of periods (active treatment or placebo) being sorted out. |
| placebo | Placebo comparator | Dietary Supplement: placebo11 days treatment with study drug, order of periods (L-lysine or placebo) being sorted out. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-lysineL-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals | Dietary supplement | L-lysine |
| placeboplacebo, 3 times a day, orally, during meals | Dietary supplement | placebo |
Primary outcome
Plasma aldosterone variation during orthostatic test
Time frame: Day 5 of treatment, at each period
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 28103616Duparc 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.
Related trials for Male
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Lefebvre, PHD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-lysine in people with Male and Healthy Volunteers, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma aldosterone variation during orthostatic test (time frame: Day 5 of treatment, at each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.