BHB TransportNCT05937893
Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)
A study testing Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans in people with BHB Transport and Alcohol Use Disorder, run by Yale University at 1 site in United States.
Trial summary
The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- BHB Transport, Alcohol Use Disorder
- What is being tested?
- Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For AUD patients: individuals assessed to be with mild to - medium severity according to the DSM-5 criteria.
- For non-dependent heavy at-risk drinkers: must be Individuals who consume more than 14 drinks per week for men or more than 8 drinks per week for women, for at least the last 2 months.
- For healthy controls: must be light drinkers not dependent on alcohol, who consume fewer than 2 drinks per week for at least the last 6 months.
- English speaking
- Can read and understand a study the consent form
Who cannot join
- Non-English speaking
- Unable to read and understand the consent form
- History of alcohol withdrawal in the last 12 months. This will reduce chances of a volunteer having withdrawal symptoms in the middle of the experiment.
- Participants with a history of psychiatric conditions (that include PTSD, schizophrenia, and bipolar disorders), or a history of neurological conditions
- Women who test positive on a pregnancy test collected on either the screening visit or day of the study.
- Healthy subjects identified with substance use with the exception of tobacco and alcohol will be excluded.
- AC subjects identified with substance use, with the exception of tobacco, alcohol, and mild cannabis use disorder (based on the DSM-5 criteria during the medical history) in the last 6 months, will be excluded.
- Persons unable to refrain from alcohol use for 48 hours and undergo a 10-hour fast prior to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Anlyan Center (TAC)
New Haven, Connecticut, 06519
About this study
The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain.
Read the detailed description
The primary objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain. Furthermore, BHB levels in identified brain regions will be compared against measures of craving.
The secondary objective of this study is to investigate if GABA levels will be elevated in key brain regions relative to the baseline scan in AC subjects due to preferential BHB metabolism. The goal is to acquire preliminary data to apply for an R01 or equivalent grant submission to pursue this metabolic therapy in greater detail using the state-of-the-art MRSI platform at Yale University to study alcohol use disorders.
- Conditions
- BHB Transport, Alcohol Use Disorder
- Being tested
- Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans
- Keywords
- BHB, AUD
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scansOther
Following baseline scans, the participant will orally consume the keto-ester, for subsequent scans which will include repeated BHB MRSI acquisitions to dynamically measure BHB labeling in the brain, followed by a final GABA MRSI acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol consumer (AC) participants | Other | Adult volunteers who are alcohol consumers drawn from both an outpatient population and recruited heavy drinkers from the community. Receives: Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans |
| Healthy participants | Other | Healthy adult volunteers who are not dependent on alcohol. Receives: Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BHB levels in the brain
β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.
Measured: Approximately 90 minutes after Baseline Assessment
Secondary outcomes (1)
Change in GABA levels in the brain
GABA levels will be assessed in the brain via MRSI to determine if they are elevated in key brain regions relative to the baseline scan.
Measured: Approximately 90 minutes after Baseline Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start14 Aug 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BHB TransportStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chathura Kumaragamage, PhD, Principal investigator, Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937893
- Sponsor's protocol ID
- 2000035050
- Other IDs
- 000
- Status last verified
- Dec 2024
- First submitted
- 30 Jun 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this study be submitted to the NIMH data archive (NDA) at the NIH.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)
- ClinicalTrials.gov ID
- NCT05937893
- Acronym / sponsor ID
- 2000035050
- Conditions
- BHB Transport, Alcohol Use Disorder
- Keywords
- BHB, AUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 10 Jul 2023 (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.
The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain.
Detailed description
The primary objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain. Furthermore, BHB levels in identified brain regions will be compared against measures of craving.
The secondary objective of this study is to investigate if GABA levels will be elevated in key brain regions relative to the baseline scan in AC subjects due to preferential BHB metabolism. The goal is to acquire preliminary data to apply for an R01 or equivalent grant submission to pursue this metabolic therapy in greater detail using the state-of-the-art MRSI platform at Yale University to study alcohol use disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol consumer (AC) participants | Other | Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scansAdult volunteers who are alcohol consumers drawn from both an outpatient population and recruited heavy drinkers from the community. |
| Healthy participants | Other | Other: Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scansHealthy adult volunteers who are not dependent on alcohol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For AUD patients: individuals assessed to be with mild to - medium severity according to the DSM-5 criteria.
- For non-dependent heavy at-risk drinkers: must be Individuals who consume more than 14 drinks per week for men or more than 8 drinks per week for women, for at least the last 2 months.
- For healthy controls: must be light drinkers not dependent on alcohol, who consume fewer than 2 drinks per week for at least the last 6 months.
- English speaking
- Can read and understand a study the consent form
Key exclusion criteria (8 listed)
- Non-English speaking
- Unable to read and understand the consent form
- History of alcohol withdrawal in the last 12 months. This will reduce chances of a volunteer having withdrawal symptoms in the middle of the experiment.
- Participants with a history of psychiatric conditions (that include PTSD, schizophrenia, and bipolar disorders), or a history of neurological conditions
- Women who test positive on a pregnancy test collected on either the screening visit or day of the study.
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 |
|---|---|---|
| Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scansFollowing baseline scans, the participant will orally consume the keto-ester, for subsequent scans which will include repeated BHB MRSI acquisitions to dynamically measure BHB labeling in the brain, followed by a final GABA MRSI acquisition. | Other | Alcohol consumer (AC) participants, Healthy participants |
Primary outcome
Change in BHB levels in the brain
Time frame: Approximately 90 minutes after Baseline Assessment
β-hydroxybutyrate blood levels in the brain will be assessed via MRSI.
1 secondary outcome
Change in GABA levels in the brain
Time frame: Approximately 90 minutes after Baseline Assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. De-identified data from this study be submitted to the NIMH data archive (NDA) at the NIH.
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. This study is not recruiting at the moment.
Chathura Kumaragamage, PhD principal investigator
Bioimaging SciencesMagnetic Resonance SpectroscopyRadiology & Biomedical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keto-ester followed by Magnetic Resonance Spectroscopic Imaging (MRSI) scans in people with BHB Transport and Alcohol Use Disorder, run by Yale University 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 11 Dec 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BHB levels in the brain (time frame: Approximately 90 minutes after Baseline Assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.