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Controlled Diet for Healthy Subjects

N/A

Waitlist Available

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-diet to post-diet (1 week)

Awards & highlights

Study Summary

This trial will study the effects of lysine, an amino acid, on 2-AAA, a substance in the blood and urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-diet to post-diet (1 week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-diet to post-diet (1 week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-diet to post-diet (1 week) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Plasma 2-AAA Concentration From Baseline

Trial Design

2Treatment groups

Experimental Treatment

Group I: Normal Lysine DietExperimental Treatment1 Intervention

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.

Group II: High Lysine DietExperimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lysine

2020

N/A

~70

Controlled Diet

2020

N/A

~70

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Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,525 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment allow for people who are below the age of 35 years old?

"This particular clinical trial is only for individuals who are between 18-45 years old."

Answered by AI

Who can join this clinical trial and how do they qualify?

"This clinical trial is seeking around 80 individuals who are classified as healthy subjects (hs) and between the ages of 18-45."

Answered by AI

Are enrollment numbers still open for this research project?

"No, this study is not recruiting at this time according to the clinicaltrials.gov website. This research was first made public on August 17th 2020 and was last updated on August 25th 2022. Although 893 other studies are looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jane Ferguson 2020. "Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04417218.