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New treatment option for Ketosis
Official title Effects of Ketone Supplement and Alcohol on Brain Metabolism
ClinicalTrials.gov ID: NCT06815237
What this study is testing
- What it's testing
- The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Able to provide written informed consent and commit to completing study procedures.
- Reported on at least one day in the month before consent of consuming 2 or more standard alcoholic drinks on a single day.
You likely can't join if
- Unwilling or unable to refrain from the use of psychoactive medications, medication that may affect study results, and or alcohol, within 24 hours of...
- Current DSM-5 diagnosis of a major psychiatric disorder (other than marijuana and nicotine use disorders) as identified by clinical examination or...
- Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g...
- Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it...
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory...
- Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease...
See the full eligibility criteria
- Able to provide written informed consent and commit to completing study procedures.
- Reported on at least one day in the month before consent of consuming 2 or more standard alcoholic drinks on a single day.
- Unwilling or unable to refrain from the use of psychoactive medications, medication that may affect study results, and or alcohol, within 24 hours of the Alcohol lab, and MRI procedures (self-report, medical history...
- Current DSM-5 diagnosis of a major psychiatric disorder (other than marijuana and nicotine use disorders) as identified by clinical examination or structured interview that could interfere with study participation or...
- Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; psychotropic drugs not otherwise specified)
- Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it...
- Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may...
- Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
- Pregnant or breast-feeding
- Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
- Self-reported claustrophobia
- Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.