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NCT03255031 · ClinicalTrials.gov registry record · NA
Ketogenic Diet (KD) in Alcoholism
A NA study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- NA
- Development phase
- 53
- Enrollment target
NCT03255031: Completed NA study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03255031 is a NA study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 53 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03255031, a NA study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
Study 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.
Primary Outcome
Alcohol withdrawal symptoms were measured using the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar). The CIWA-Ar is a 10-item scale scored from 0-7, with the exception of the orientation category, scored from 0-4, used in the assessment and management of alcohol withdrawal. Score ranges from 0 - 67. Mild alcohol withdrawal is defined with a score less than or equal to 10, moderate with scores 11 to 15, and severe with any score equal to or greater than 16. Analysis was per
Interventions
- OTHER Ketogenic Diet (KD)
- OTHER Standard American (SA) Meals and Shakes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2023-02-07 |
| Phase | NA |
What the finished NCT03255031 record still lists
NCT03255031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketogenic Diet (KD) is the first listed.
NCT03255031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03255031 about?
NCT03255031 is a clinical study titled "Ketogenic Diet (KD) in Alcoholism". 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 w...
What is the current status of trial NCT03255031?
This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2017-10-24. Estimated completion is 2023-02-07.
What interventions are being tested in trial NCT03255031?
The interventions under investigation include: Ketogenic Diet (KD) (OTHER), Standard American (SA) Meals and Shakes (OTHER).
Who is sponsoring clinical trial NCT03255031?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03255031's enrollment target sits among peer trials
53 1271st of 2000 higher than 729 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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