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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05015881
Other study ID # 848992
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2021
Est. completion date December 2025

Study information

Verified date October 2023
Source University of Pennsylvania
Contact Timothy Pond, MPH
Phone 215-746-1959
Email timpond@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to learn more about how a nutritional supplement "ketone ester" (deltaG ®) has an effect on brain and heart function and on alcohol consumption in individuals with and without alcohol use disorder. The study will use Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans after a single dose of ketone ester or Placebo in 10 people with alcohol use disorder and 10 healthy control volunteers.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"
Drink a single dose of ketone ester 1.9 kcal/kg
Drug:
FDG
Echocardiogram, and 2-Deoxy-2-[18F] fluoro-D-glucose (FDG) PET scan.

Locations

Country Name City State
United States University of Pennsylvania Center for Studies of Addiction Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary FDG uptake (CMRg) in the brain and heart The primary outcome measure to be analyzed is a comparisons of AUD subjects and healthy control subjects in the amount of FDG uptake (CMRg metabolic rate of glucose) in brain and heart. 4 hours
Secondary Amount of FDG uptake (CMRg) The secondary outcome measure is the comparisons of ketone ester intervention versus intervention in FDG uptake (CMRg metabolic rate of glucose) in AUD subjects versus health control subjects. 4 hours
Secondary Amount of blood glucose (mmol/L or mg/dl) Third outcome measure is the comparisons of ketone ester intervention versus intervention in blood glucose levels in AUD subjects versus health control subjects. 4 hours
Secondary Amount of BHB (beta-hydroxybutyrate) (mmol/L) Fourth outcome measure is the comparisons of ketone ester intervention versus intervention in BHB (beta-hydroxybutyrate) (mmol/L) levels in AUD subjects versus health control subjects. 4 hours
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