Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2

NCT04417218 | Completed Results

• 2 other identifiers: 200427R01DK117144
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change in Plasma 2-AAA Concentration From Baseline

  Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).

  Change from pre-diet to post-diet (1 week)

Study Arms (2)

Normal Lysine Diet

EXPERIMENTAL

Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.

Dietary Supplement: Controlled Diet

High Lysine Diet

EXPERIMENTAL

Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).

Dietary Supplement: Lysine; Dietary Supplement: Controlled Diet

Interventions

Lysine DIETARY_SUPPLEMENT

Lysine is an essential amino acid which is acquired from dietary sources.

High Lysine Diet

Controlled Diet DIETARY_SUPPLEMENT

Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.

High Lysine Diet; Normal Lysine Diet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Interventions

Lysine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Results Point of Contact

• Title: Dr. Jane Ferguson
• Organization: Vanderbilt University Medical Center

jane.f.ferguson@vumc.org

6158759896

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cardiovascular Medicine Division

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: August 17, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)