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New treatment option for Ketogenic Diet
Official title Effects of Ketogenic Diet on Alcohol Intoxication
ClinicalTrials.gov ID: NCT07602270
What this study is testing
- What it's testing
- The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \~4 weeks of ketogenic diet intervention.
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 50. Healthy volunteers may be eligible.
You may be able to join if
- Age 21 years to 50 years old.
- Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent...
You likely can't join if
- Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study...
- Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical...
- Currently taking medication(s) 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 at screening or study visits (may be repeated once and if the result is...
- A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact...
- Currently suffering from or has a history of stroke and/or stroke related spasticity.
See the full eligibility criteria
- Age 21 years to 50 years old.
- Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.
- Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
- Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study...
- Currently taking medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise...
- Positive urine drug screen, positive for all substances but marijuana at screening or 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, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement, administration of...
- Currently suffering from or has a history of stroke and/or stroke related spasticity.
- Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture, inter-cranial bleeding or abnormal MRI (self-report, medical history).
- Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).
- Females who are pregnant or breast-feeding
- Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent people from lying comfortably flat on his/ her back for up to 2 hrs.
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 50 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.