N/A
N=47
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04417218 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Plasma 2-AAA Concentration From Baseline — -9.35; 7.02 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lysine (Dietary_supplement); Controlled Diet (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma 2-AAA Concentration From Baseline |
-9.35; 7.02 | — |
Summary
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).
Eligibility Criteria
Inclusion Criteria
- Prior participant in 2-AAA screening study.
- Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Exclusion Criteria
- Individuals who currently use tobacco products.
- Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
- Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
- Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.
- Individuals who are pregnant or lactating
- Inability to provide written or electronic informed consent
- Inability to fast for 8 hours
Data sourced from ClinicalTrials.gov (NCT04417218). 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.