Ketogenic Diet (KD) in Alcoholism
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|ClinicalTrials.gov Identifier: NCT03255031|
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : July 27, 2018
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.
To test the effects of a ketogenic diet on alcohol withdrawal symptoms.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Dietary Supplement: Ketogenic Diet (KD) Dietary Supplement: Standard American (SA) Meals and Shakes||Early Phase 1|
Alcohol intoxication leads to marked reductions in brain glucose metabolism that reflect in part the use of ketones (including acetate) as alternative energy sources by the brain during intoxication. With repeated alcohol exposure both clinical and preclinical studies have shown a shift of brain substrate preference towards ketones. This has led us to question the potential value of a ketogenic diet in alcohol detoxification in order to prevent the ketone deprivation that would follow alcohol detoxification in alcoholics.
Objectives: Here we propose a blinded randomized design to assess the effects of a ketogenic diet on symptoms of alcohol withdrawal and on brain function in alcoholics undergoing inpatient treatment of alcohol detoxification. We hypothesize that a ketogenic diet will increase acetate levels in brain resulting in improved brain function in alcoholics as well as a reduction of alcohol withdrawal symptoms during detoxification.
Study population: Participants diagnosed with alcohol use disorder (AUD) as per DSM IV or DSM 5. Males and females ages 18 years and older will be included.
Design: This will include an inpatient component and outpatient follow-up. Patients are admitted to the Clinical Center (CC) for detoxification, where they undergo treatment as usual (TAU) and will be randomized into a regular versus a ketogenic diet. Patients will be given benzodiazepines only if withdrawal symptoms emerge while receiving either the ketogenic or the regular diet. Within 2-6 days after admission, all patients will undergo an MRI (brain structure and function, functional connectivity and spectroscopy, i.e. MRS) and a battery of neuropsychological tests (NP). MRI scans will also be obtained in week 2. After 3 weeks of inpatient care the MRI scans and NP studies will be repeated. We will complete all study procedures in n=25 patients with AUD with the ketogenic diet and n=25 with the regular diet.
Outcome parameters: Main outcome: To assess the effects of a ketogenic diet in patients hospitalized for the treatment of alcohol detoxification, on: (1) withdrawal symptoms including the need of medications to control them (benzodiazepines); (2) brain function as assessed by fMRI (at rest and during task conditions), (3) MRS, and (4) structural MRI. Secondary Outcomes: To assess the effects of a ketogenic diet on performance of cognitive tests, sleep, mood and craving.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Ketogenic Diet (KD) in Alcoholism|
|Actual Study Start Date :||October 24, 2017|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: KD Diet meals and shakes
3 week KD diet
Dietary Supplement: Ketogenic Diet (KD)
Ketogenic Diet (KD) Meals and Shakes: Participants will be randomized to a meal plan of a ketogenic diet (KD) at the time they sign the consent (day 1 or 2 of admission). For each meal at breakfast, lunch and dinner, the diets will consist of a KD meal depending on treatment randomization. Compliance tests are done daily with a urine test measuring ketone levels. To ensure that the diet is double blind in both the outpatient and inpatient phases, solid snacks are always ketogenic and shakes are KD.
Experimental: SA Diet meals and shakes
3 week SA diet
Dietary Supplement: Standard American (SA) Meals and Shakes
Standard American (SA) Meals and Shakes: Participants will be randomized to a meal plan of standard American (SA) diet at the time they sign the consent (day 1 or 2 of admission). For each meal at breakfast, lunch and dinner, the diet will consist of a SA meal (carbohydrate rich) depending on treatment randomization. Compliance tests are done daily with a urine test test measuring ketone levels. To ensure that the diet is double blind in both the outpatient and inpatient phases, solid snacks are always ketogenic and shakes are SA.
- To assess ketogenic diet on withdrawal ratings (CIWA) and Benzodiazepine use during withdrawal in the first week of detoxification. [ Time Frame: 3 years ]
- To assess ketogenic diet on brain function (during rest and activation assessed with fMRI), neurochemistry (assessed with MRS) and structure (assessed with MRI). [ Time Frame: 3 years ]
- To assess ketogenic diet on NP performance. [ Time Frame: 3 years ]
- To determine if ketogenic diet improves: 1. sleep. 2. mood. 3. alcohol craving. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255031
|Contact: Megan S Carraco||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Corinde E Wiers||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|