The Effect of Acute Lysine Administration on α-aminoadipic Acid

NCT02756117 | Completed Phase 1

• 1 other identifier: 160520
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy; Pre-diabetic

Outcome Measures

Primary Outcomes (1)

• Change in plasma 2-AAA from baseline to peak post-lysine ingestion (anticipated 2-4 hours post-ingestion)

  The primary goal is to detect whether there is a measurable increase in 2-AAA in plasma following lysine administration. Samples will be measured at baseline (pre-ingestion) and serially post-ingestion. Relative concentrations are determined through mass spectrometry, and expressed in arbitrary units.

  Baseline and 2-4 hours

Secondary Outcomes (1)

• Change in urinary 2-AAA from baseline to peak post-lysine ingestion (anticipated 2-4 hours post-ingestion)

  Baseline and 2-4 hours

Study Arms (1)

Healthy

EXPERIMENTAL

10 Healthy subjects will be enrolled and each will undergo study procedures at one study visit. After screening and consent have been conducted over the phone, subjects will participate in the study procedures. Subjects will arrive in a fasting state (no eat or drink for 8 hours, excluding water). Following collection of blood pressure, height, weight, and a urine and blood sample, subjects will be given an oral bolus of L-lysine (10 g) in 100 ml water. This amount of lysine is equivalent to that which is found in a 10oz. serving of beef. Subjects will provide additional urine and blood samples serially post-ingestion. Because blood draws will be collected through an IV, Normal (0.9%) Saline (NS) will be infused at a rate of 10 ml/hr to flush the canula prior to each blood draw. All subjects will undergo the same procedures and interventions.

Drug: L-Lysine; Drug: Normal (0.9%) Saline

Interventions

L-Lysine DRUG

Healthy

Normal (0.9%) Saline DRUG

Also known as: NS

Healthy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Vanderbilt University: lead

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Lysine; Sodium Chloride

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jane F Ferguson, PhD

  Vanderbilt Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share