20 Participants NeededMy employer runs this trial

Ketogenic Diet for Alcohol Intoxication

TS
CL
Overseen ByCindy Li, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a ketogenic diet affects brain function and alcohol's immediate effects. Participants will follow this low-carb, high-fat diet for about four weeks, with lab visits to test alcohol tolerance and brain activity. Researchers will use MRIs to assess brain energy levels and specific chemicals. The study seeks individuals who have recently consumed at least two alcoholic drinks in one day and are willing to adhere to the diet and attend lab visits. As an unphased trial, it offers a unique opportunity to contribute to scientific understanding of diet and brain health.

Will I have to stop taking my current medications?

The trial requires participants to refrain from using psychoactive medications or any medication that may affect study results within 24 hours of the alcohol lab procedures. Additionally, if you are currently taking medications that could interfere with the study or make participation hazardous, you may not be eligible to participate.

What prior data suggests that the ketogenic diet is safe for use in this study?

Research has shown that the ketogenic diet might be safe and easy to follow for prospective trial participants. Studies have found that individuals on this diet reported fewer alcohol cravings and experienced less severe withdrawal symptoms. In some cases, it even helped them control their alcohol intake, suggesting that the diet doesn't cause major side effects for most people.

However, these findings primarily come from studies focused on alcohol use disorder, not specifically on alcohol intoxication. Therefore, while the ketogenic diet appears generally safe, discussing any concerns with a doctor before starting the diet is important.12345

Why are researchers excited about this trial?

Most treatments for alcohol intoxication focus on managing symptoms and supporting the body's recovery through methods like hydration and medication to alleviate discomfort. However, the ketogenic diet is unique because it targets the body's metabolism by shifting it from burning carbohydrates to burning fats, which produces ketones that may help in alcohol metabolism. Researchers are excited about this treatment because it offers a nutritional approach that might reduce alcohol's impact on the brain and body more effectively than current options. This innovative angle could potentially lead to faster recovery times and a new avenue for managing alcohol intoxication.

What evidence suggests that the ketogenic diet might be an effective treatment for alcohol intoxication?

Research has shown that a ketogenic diet, high in fats and low in carbohydrates, may reduce the urge to drink alcohol and ease withdrawal symptoms. Studies have found that people on this diet report less desire for alcohol and milder withdrawal symptoms. Evidence from both human and animal studies suggests that a ketogenic diet can lead to reduced alcohol consumption. This trial will test the effects of a 4-week ketogenic diet intervention on alcohol-related issues. The diet appears to improve how the brain uses energy, which might help control cravings. Overall, early research suggests that a ketogenic diet could be a promising approach for addressing alcohol-related issues.12367

Who Is on the Research Team?

CW

Corinde Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

HK

Henry Kranzler, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults aged 21-50 who have had at least one day in the past month where they drank two or more alcoholic drinks. Participants must be willing to follow a ketogenic diet and complete all study procedures.

Inclusion Criteria

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
I am between 21 and 50 years old.

Exclusion Criteria

Weight greater than 225 lbs
Positive urine drug screen for all substances but marijuana at screening or study visits (may be repeated once; negative repeat is not exclusionary)
Contraindication to MRI including ferromagnetic objects, claustrophobia, fear of enclosed spaces, or medical conditions preventing lying flat for up to 2 hours
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Dietary Intervention

Participants adhere to a 4-week ketogenic diet with meals provided by a commercial meal service. Compliance is monitored through daily urine ketone tests.

4 weeks
Weekly check-ins (virtual)

Lab Visits

Participants undergo lab visits at weeks 2 and 4, including MRI scans, alcohol tolerance tests, and blood sample collection.

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the dietary intervention.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketogenic Diet

Trial Overview

The study tests how following a ketogenic (low-carb, high-fat) diet for about four weeks affects brain function and alcohol tolerance. Participants will undergo lab visits with alcohol challenges, blood draws, and MRI scans before and after the diet.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ketogenic dietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Citations

Nutritional Ketosis as a Potential Treatment for Alcohol Use ...

There is evidence that KD and KE reduce appetite and food intake (15, 46) and rodent studies have shown that nutritional ketosis reduces alcohol intake. Rats ...

Ketogenic diet reduces a neurobiological craving signature ...

We recently found that a KD intervention reduced alcohol withdrawal severity and alcohol craving in individuals with an AUD undergoing inpatient detoxification, ...

Brain glutamate and sleep efficiency associations following ...

We previously showed that ketogenic diet (KD) was effective in curbing alcohol withdrawal and craving in individuals with alcohol use disorder (AUD).

Effects of Ketogenic Diet on Alcohol Intoxication

The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol.

A ketogenic diet reduces hepatic alcohol metabolism and ...

In a model of alcohol dependence, the KD reduced alcohol consumption in male, but not female, rats compared with chow-fed rats. These findings ...

Effects of ketogenic diet and ketone monoester supplement on ...

We previously reported that a ketogenic diet during alcohol exposure reduced acute withdrawal symptoms in rats. Here, our goals were to test whether 1) we could ...

Ketogenic Diet for Alcohol Intoxication

The study tests how following a ketogenic (low-carb, high-fat) diet for about four weeks affects brain function and alcohol tolerance.