Phase 1 N=2 Basic Science

The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03063476 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Peak Plasma 2-AAA Concentration Percentage Change From Baseline — 63.4 Percentage Change

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: C-13 labeled Lysine (Drug); Normal saline (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Plasma 2-AAA Concentration Percentage Change From Baseline	63.4	—
SECONDARY Peak Urinary 2-AAA Concentration Percentage Change From Baseline	39	—

Summary

This sub-study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.

Eligibility Criteria

Inclusion Criteria

BMI 18 to <25 kg/m2
Men and women ages 18-45 years

Exclusion Criteria

Current use of prescription medications (apart from hormonal birth control)
Current use of amino acid supplements (including branched-chain amino acids) or supplemental protein (habitual consumption of protein powder, bars, shakes), and unwilling to temporarily discontinue use (1 week prior to study visit)
Individuals who currently use tobacco products or have done so in the previous 30 days
Prior or current cardiovascular disease, renal disease, or liver disease
Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)
Atrial fibrillation
Bleeding disorder or anemia
Positive pregnancy test
Women who are breastfeeding
Participation in another clinical trial within the previous 6 weeks prior to the study visit
Inability to provide written informed consent
Inability to fast for 8 hours

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03063476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.