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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03063476

Run by

Vanderbilt University Medical Center

People needed

2

Starts

2017-03-01

Expected to finish

2017-05-18

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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