Ketogenic Diet and Alcohol Intoxication: Can ketosis affect brain function and alcohol response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults with alcohol use concerns will follow a ketogenic diet for about four weeks and undergo three lab visits to measure brain chemistry, alcohol tolerance, and blood biomarkers. Lab visits include an alcohol tolerance test with controlled drinking and MRI scans at the start and after four weeks to assess NAD, lactate, glutamate, and GABA in the brain. The study uses breath alcohol testing, blood draws, urine screens, and safety assessments to monitor effects and eligibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 21 years to 50 years old.
2. 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.

Exclusion Criteria:

1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
2. 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 participation or make it hazardous for the subject.
3. 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 specified)
4. 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).
5. 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 ketogenic diet, or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
6. Currently suffering from or has a history of stroke and/or stroke related spasticity.
7. 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).
8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight to individuals).
9. Females who are pregnant or breast-feeding
10. Contraindication to MRI, including presence of ferromagnetic objects, claustrophobia or fear of enclosed, medical conditions that prevent subjects from lying comfortably flat on his/ her back for up to 2 hrs.

Where it's running

• Center for Studies of Addiction
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Corinde Wiers, Ph.D. — University of Pennsylvania
• Study coordinator: Timothy S Pond, MPH
• Email: timpond@pennmedicine.upenn.edu
• Phone: 215-746-1959

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How alcohol changes the social brain during paired interactions

  This study tests whether drinking alcohol changes brain activity and social bonding during conversations between pairs of regular social drinkers aged 21–30.

  Recruiting University of Illinois at Urbana-Champaign · Champaign, Illinois and 1 other locations · NCT07125534

• Examining alcohol use in romantic relationships

  This study is testing how drinking alcohol affects couples' relationships by having them drink either alcohol or non-alcoholic drinks and then answer questions about their relationship over time.

  Recruiting Carnegie Mellon University · Pittsburgh, Pennsylvania · NCT06822257

• Telehealth program using blood tests to help treat alcohol use disorder

  This study is testing a new telehealth program that uses blood tests to help people with alcohol use disorder by combining online therapy with rewards for submitting their test results.

  Recruiting Washington State University · Spokane, Washington · NCT06265506

• Understanding how alcohol affects young adults with bipolar disorder

  This study looks at how alcohol affects young adults with bipolar disorder compared to their peers to see if it leads to problems with drinking over time.

  Recruiting University of Texas at Austin · Austin, Texas · NCT05838274

• Testing a wearable device to measure alcohol levels in real-world settings

  This study is testing a new wearable device that measures alcohol levels in your body to see how accurately it works in everyday situations.

  Recruiting University of Illinois at Urbana-Champaign · Champaign, Illinois · NCT05692830

• Web-based intervention for military spouses to reduce alcohol use

  This study tests a new online program designed to help military spouses cut down on alcohol use and encourage their service member partners to seek help.

  Recruiting Stanford University · Palo Alto, California · NCT05619185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.