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Glutamine Metabolism Assessment in Healthy Subjects

N/A

Recruiting

Led By Wilson Gonsalves, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Ages 18-60

Be between 18 and 65 years old

Must not have

Renal Failure

Active steroid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 hour

Summary

This trial will compare the effectiveness of two methods of measuring how well glutamine is used by plasma cells in the bone marrow.

Who is the study for?

This trial is for healthy adults aged 18-60 who can give written consent. It's not suitable for pregnant individuals, those with liver disease, kidney failure, anemia (low hemoglobin levels), heavy alcohol users (>2 drinks per day), people with a BMI over 30, or anyone currently using steroids.

What is being tested?

The study is testing how bone marrow plasma cells in healthy subjects use glutamine. Participants will undergo a bone marrow aspiration and receive a special form of glutamine labeled with carbon-13 to track its utilization in the body compared to lab-based tests.

What are the potential side effects?

Potential side effects may include discomfort at the aspiration site, bruising, bleeding or infection risks from the procedure. The infused labeled glutamine is expected to have minimal side effects as it's similar to naturally occurring amino acids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney failure.

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I am currently taking steroids.

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I have an active liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: In VivoExperimental Treatment2 Interventions

Infusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration.

Group II: Ex VivoPlacebo Group1 Intervention

Healthy subjects will undergoing a bone marrow aspiration and then the plasma cells acquired will be cultured ex vivo in cell culture media containing 5-13C-Glutamine.

0 / 4Eligibility criteria met