Clinical Trials Logo

Clinical Trial Summary

The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).


Clinical Trial Description

The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Healthy participants will undergo three randomly assigned dietary interventions, each lasting three days, followed by a study lab visit day on day 4. The three interventions are: (1) Eat a ketogenic diet for 3 days, (2) eat a control diet for 3 days with a ketone supplement drink, and (3) eat a control diet for 3 days. The dietary interventions will be spaced 1 week apart. The ketone supplement drink (Kenetik, Vitanav inc, Washington DC) is a dietary supplement that has been extensively studied in humans and is designated by the FDA as Generally Recognized as Safe (GRAS). Its use in this study is experimental. On the day of the 3 labs visits days, magnetic resonance imaging (MRI) will be used to study the brain. Specifically, levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Following the scans, participants will be provided a dose of alcohol that will elevate participants breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06065657
Study type Interventional
Source University of Pennsylvania
Contact Timothy S Pond, MPH
Phone 215-746-1959
Email timpond@upenn.edu
Status Recruiting
Phase Phase 2/Phase 3
Start date January 18, 2023
Completion date December 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Completed NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1