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Ketogenic Diet for Alcoholism
Phase < 1
Waitlist Available
Led By Gene-Jack Wang, M.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights
Study Summary
This trial is testing the effects of a ketogenic diet on alcohol withdrawal symptoms. Eligible participants must be 18 years or older, moderate or severe alcohol drinkers, and seeking treatment for alcohol use. The study will last 3 weeks, during which participants will consume either a KD or Standard American diet.
Who is the study for?
Adults over 18 with moderate to severe alcohol use disorder (AUD) seeking treatment can join this trial. They must be part of the NIAAA inpatient program, not have significant medical conditions affecting brain function or MRI safety issues, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests if a high-fat, low-carb ketogenic diet can ease withdrawal symptoms in people with AUD compared to standard American meals. It includes a 3-week clinic stay with dietary monitoring, breathalyzer tests, MRIs while doing tasks, sleep/wake assessments, cognitive tests, heart exams and follow-up calls.See study design
What are the potential side effects?
Potential side effects from the ketogenic diet may include digestive discomfort like constipation or diarrhea, changes in mood or alertness due to shifts in diet composition. Participants might also experience fatigue as their bodies adjust to using fats for energy instead of carbohydrates.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of ketogenic diet
Secondary outcome measures
To assess the effects of a ketogenic diet in alcohol use disorder (AUD) subjects.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Diet Randomization - Active ComparatorActive Control1 Intervention
Ketogenic diet (KD) liquid diet consists of snacks and shakes 3x p/day (high in fat). SA will receive the same KD solid snacks, in order to keep the diets blind to participants. KD will be eucaloric such that a standard equation based on weight, height, sex and age will be used to determine how many calories are provided to each participant.
Group II: Diet Randomization - Placebo ComparatorPlacebo Group1 Intervention
Standard American (SA) diet consists of KD snacks and shakes 3x p/day (high in fat) in the proportions of carbohydrates, protein and fat of traditional western diet. SA will receive the same KD solid snacks, in order to keep the diets blind to participants. SA will be eucaloric such that a standard equation based on weight, height, sex and age will be used to determine how many calories are provided to each participant.
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Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
799 Previous Clinical Trials
1,362,458 Total Patients Enrolled
422 Trials studying Alcoholism
985,155 Patients Enrolled for Alcoholism
Gene-Jack Wang, M.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
5 Previous Clinical Trials
548 Total Patients Enrolled
1 Trials studying Alcoholism
74 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a severe head injury where you lost consciousness for more than 30 minutes.You have allergies to milk or soy.You have a problem with drinking too much alcohol (AUD).You have reported alcohol as your preferred drug.You are actively seeking treatment for your alcohol use disorder (as reported by yourself).You have been drinking heavily for at least 5 years, which means having 5 or more drinks per day for men, or 4 or more drinks per day for women, on at least 5 different days per month.You are unable to lie comfortably flat on your back for up to 2 hours during an MRI scan (as reported by yourself).
Research Study Groups:
This trial has the following groups:- Group 1: Diet Randomization - Active Comparator
- Group 2: Diet Randomization - Placebo Comparator
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently openings for participants for this experiment?
"Affirmative. According to the clinicaltrials.gov page, this trial is still open for enrollment and has been since October 24th 2017. An update was issued on July 6th 2022 regarding recruitment; 100 individuals are needed from 1 site in particular."
Answered by AI
How many participants are being recruited for this medical experiment?
"Indeed, the information accessible on clinicaltrials.gov indicates that this experiment is actively recruiting patients. It was initially uploaded to the website on October 24th 2017 and most recently updated on July 6th 2022. They seek 100 volunteers from one site for their trial."
Answered by AI
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