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Effects of Ketone Supplement and Alcohol on Brain Metabolism

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 20 to 60 Primary completion date: Feb 2028 to May 31, 2029 · Completion date: Feb 2029 to May 31, 2029 · Study title expanded, about 1 wordv5 Show 3 more changesShow less
    • Primary completion date: Feb 2028 to May 31, 2029
    • Completion date: Feb 2029 to May 31, 2029
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to May 13, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2025 to May 13, 2025
    • Site details revised
  3. Start date: Mar 2025 to Apr 2025 Study description shortened, about 5 wordsv3 Show 1 more changeShow less
    • Study description shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints: details revised at 3 of 3 entriesv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention. These interventions will be randomly assigned (meaning everyone receives all 3 interventions, but in different orders).
Trial Details
NCT Number NCT06815237
Lead Sponsor University of Pennsylvania
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Ketosis, Alcohol Drinking, MRI
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov