NCT04417218 is a NA clinical trial of Lysine in Healthy, sponsored by Vanderbilt University Medical Center.

Who is sponsoring NCT04417218?

NCT04417218 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT04417218?

Interventions in NCT04417218: Lysine, Controlled Diet.

Is NCT04417218 still recruiting?

NCT04417218 is currently completed. Last updated 21 December 2023.

Are results published for NCT04417218?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-21 · How we verify

NCT04417218

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2

Completed NA Results posted Last updated 21 December 2023

What this trial tests

NA trial testing Lysine in Healthy in 67 participants. Completed in 1 January 2023.

Timeline

17 August 2020

Primary endpoint
1 January 2023

1 January 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	67
Start date	17 August 2020
Primary completion	1 January 2023
Estimated completion	1 January 2023
Sites	1 location across United States

Drugs / interventions tested

Lysine (LYSINE) — full drug profile →
Controlled Diet

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Plasma 2-AAA Concentration From Baseline Primary · Change from pre-diet to post-diet (1 week)

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).

Group	Value	95% CI
Normal Lysine Diet	-9.35	± 30.3
High Lysine Diet	7.02	± 23.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events data were collected over the 4 week study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal Lysine Diet

Serious: 0/47 (0%)

Deaths: 0/47

High Lysine Diet

Serious: 0/46 (0%)

Deaths: 0/46

Other adverse events (5 terms — click to expand)

Reaction	System	Normal Lysine Diet	High Lysine Diet
Bloating	Gastrointestinal disorders	—	—
Changes in mood	Psychiatric disorders	—	—
Headache	Nervous system disorders	—	—
Change in mood	Psychiatric disorders	—	—
Bruising	Blood and lymphatic system disorders	—	—

Data from ClinicalTrials.gov NCT04417218 adverse events section.

Sponsor's own description

This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Metabolite 2-aminoadipic acid: implications for metabolic disorders and therapeutic opportunities.
Shi W, Yang Z, Fu P, Yang Y. · · 2025 · cited 4× · PMID 40432896 · DOI 10.3389/fphar.2025.1569020
The consumption of animal products is associated with plasma levels of alpha-aminoadipic acid (2-AAA).
Antonetti OR, Desine S, Smith HM, Robles ME, et al · · 2024 · cited 1× · PMID 38658223 · DOI 10.1016/j.numecd.2024.03.009

Verify or expand the search:

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Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

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NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04417218 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 21 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04417218.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing