HealthyNCT03384108
In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells
A study testing 5-13C-Glutamine and Bone marrow aspiration in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5-13C-Glutamine and Bone marrow aspiration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-60
- Able to provide written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Wilson Gonsalves, MD, 5072842511, gonsalves.wilson@mayo.edu
About this study
Official title: In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells in Healthy Subjects Using Stable Isotope Resolved Metabolomics: A Pilot Study
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
Read the detailed description
Twenty healthy adult study participants between the ages of 18 and 60 years will be recruited to participate in this pilot study that will include two groups: a) Ex Vivo group (10 volunteers) and b) In Vivo group (10 volunteers). Volunteers will be recruited to either group in a sequential alternating fashion.
In vivo 13C SIRM studies evaluating the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells.
- Conditions
- Healthy
- Being tested
- 5-13C-Glutamine, Bone marrow aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-13C-GlutamineOther
Intravenous infusion of 5-13C-Glutamine
Bone marrow aspiration of bone marrow aspirate
| Study group | Role | What they receive |
|---|---|---|
| In Vivo | Experimental | Infusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration. Receives: Other: 5-13C-Glutamine; Other: Bone marrow aspiration |
| Ex Vivo | Placebo comparator | 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. Receives: Other: Bone marrow aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry.
The plasma cells obtained from the bone marrow aspiration will be processed to determine the percent of 13-carbon enrichment in the various molecules of the TCA cycle within the plasma cells. The outcomes will be reported as a percentage. E.G. 5% of glutamine is labeled with 13-Carbon; e.g. 4% of glutamate is labeled with 13-carbon etc.
Measured: Through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Sep 2017
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In Vivo vs. Ex Vivo assessment of 5-13C-Glutamine incorporation by plasma cells via a bone marrow aspiration.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson I. Gonsalves, M.D., Mayo Clinic
- Investigators
- Wilson Gonsalves, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384108
- Sponsor's protocol ID
- 16-008291
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2017
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.
PubMed 33308307
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells in Healthy Subjects Using Stable Isotope Resolved Metabolomics: A Pilot Study
- ClinicalTrials.gov ID
- NCT03384108
- Acronym / sponsor ID
- 16-008291
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Twenty healthy adult study participants between the ages of 18 and 60 years will be recruited to participate in this pilot study that will include two groups: a) Ex Vivo group (10 volunteers) and b) In Vivo group (10 volunteers). Volunteers will be recruited to either group in a sequential alternating fashion.
In vivo 13C SIRM studies evaluating the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Vivo vs. Ex Vivo assessment of 5-13C-Glutamine incorporation by plasma cells via a bone marrow aspiration.
| Arm | Type | Receives |
|---|---|---|
| In Vivo | Experimental | Other: 5-13C-Glutamine, Other: Bone marrow aspirationInfusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration. |
| Ex Vivo | Placebo comparator | Other: Bone marrow aspirationHealthy 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 18-60
- Able to provide written consent
Key exclusion criteria (7 listed)
- Renal Failure
- Pregnancy
- Active steroid use
- Active liver Disease
- Anemia (Hemoglobin < 12.5 g/dL in men and < 11.5 g/dL in women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-13C-GlutamineIntravenous infusion of 5-13C-Glutamine | Other | In Vivo |
| Bone marrow aspirationBone marrow aspiration of bone marrow aspirate | Other | Ex Vivo, In Vivo |
Primary outcome
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
The plasma cells obtained from the bone marrow aspiration will be processed to determine the percent of 13-carbon enrichment in the various molecules of the TCA cycle within the plasma cells. The outcomes will be reported as a percentage. E.G. 5% of glutamine is labeled with 13-Carbon; e.g. 4% of glutamate is labeled with 13-carbon etc.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 33308307Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wilson Gonsalves, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-13C-Glutamine and Bone marrow aspiration in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilson Gonsalves (5072842511, gonsalves.wilson@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.