At a glance
ClinicalIndex Comparison Record- ✓DSM-IV diagnosis of alcohol dependence/abuse OR DSM-5 diagnosis of moderate/severe AUD
- ✓Age 18 years or older
- ✓Minimum 5-year history of heavy drinking (≥5 drinks/day on ≥5 days/month for men; ≥4 drinks/day on ≥5 days/month for women)
- ✓Currently seeking treatment for AUD
- ✕Current DSM-IV or DSM-5 diagnosis of major psychiatric disorder (other than alcohol/nicotine or mild/moderate substance use disorders) requiring hospitalization or daily medication >4 weeks in past year
- ✕Chronic benzodiazepine use prior to alcohol detoxification
- ✕Major medical conditions affecting brain function or incompatible with ketogenic diet (epilepsy, diabetes, liver disease, kidney disease, kidney stones, chronic metabolic acidosis, cardiomyopathy)
- ✕Clinically significant laboratory findings affecting brain function (e.g., HIV+)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ketogenic Diet (KD) in Alcoholism
In Brief
A clinical study evaluating Ketogenic Diet (KD) and Standard American (SA) Meals and Shakes for Alcoholism. Completed, enrolled 53 participants across 1 site.
Detailed Summary
Background: A ketogenic diet (KD) is high in fat and low in carbohydrates. Research has shown that a KD can lessen tremor in animals withdrawing from alcohol. KD can also help people who have difficulties with thinking, sleep, and mood. Researchers want to see if KD can lessen symptoms of alcohol withdrawal in people with alcohol use disorder. Objective: To test the effects of a ketogenic diet on alcohol withdrawal symptoms. Eligibility: Adults 18 years or older who are moderate or severe alcohol drinkers and are seeking treatment for alcohol use. They must be in the NIAAA inpatient alcohol treatment program. Design: Participants will be screened under another protocol. They will have a medical and psychiatric history, physical exam, and blood and urine tests. Participants will have a breath test for alcohol. The study will be done in a 3-week stay in the clinic. Participants will get either a KD or Standard American diet. Participants will have breathalyzer, blood, and urine tests. Participants will have magnetic resonance imaging (MRI) scans. The scanner is a cylinder in a magnetic field. They will lie on a table that slides in and out of the cylinder. They will do tasks on a computer during the scan. Participants will have tests of thinking, memory, and attention. Participants will have their sleeping and waking measured. They will wear a device like a headband held in place with elastic straps. Several electrodes will be placed on the body. Participants will have heart tests. Participants will wear an activity monitor on the wrist. After the clinic stay, participants will be called by phone about 5 times over 3 months.
Study Details
Timeline
Interventions
For each meal at breakfast, lunch and dinner, the diets will consist of ketogenic diet (KD) meal. Compliance tests are done twice a week with a blood test measuring ketone levels.
For each meal at breakfast, lunch and dinner, the diets will consist of SA meal (carbohydrate rich) KD meal. Compliance tests are done twice a week with a blood test measuring ketone levels.