Phase 1
Completed N=2
The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)
Healthy
Source: ClinicalTrials.gov NCT03063476 ↗
Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Peak Plasma 2-AAA Concentration Percentage Change From Baseline — 63.4 Percentage Change
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.
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 | — |
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
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. Informational only — not medical advice.