Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03384108

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

5-13C-Glutamine

Bone marrow aspiration

Study Details

Brief summary:

This pilot study will first establish the feasibility of an in vivo methodology of assessing the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells from healthy subjects while comparing it to an ex vivo approach

Conditions

Healthy

Study ID

NCT03384108

Start date

Sep 1, 2017

Status verified date

Feb, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 18-60
  • Able to provide written consent

Exclusion Criteria:

  • Renal Failure
  • Pregnancy
  • Active steroid use
  • Active liver Disease
  • Anemia (Hemoglobin < 12.5 g/dL in men and < 11.5 g/dL in women)
  • H/O alcohol use (average > 2 drinks per day)
  • BMI > 30

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: In Vivo

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

placebo comparator: Ex Vivo

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.

Interventions

5-13C-Glutamine

Intravenous infusion of 5-13C-Glutamine

Bone marrow aspiration

Bone marrow aspiration of bone marrow aspirate

Primary outcome measure

  • Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry. [ Time Frame: Through study completion, an average of 1 hour ]

Central Contacts and Locations

Central contacts

Wilson Gonsalves

5072842511gonsalves.wilson@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Wilson Gonsalves, MD

5072842511gonsalves.wilson@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-25.