Status:
COMPLETED
Ketone Supplementation in Adolescents Post-Concussion
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Concussion, Mild
Concussion, Severe
Eligibility:
All Genders
13-19 years
Phase:
NA
Brief Summary
Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substan...
Detailed Description
In this randomized design, study participants (n=30) will take a supplement 3 times per day for 14 days and will be followed throughout completion of the concussion protocol, up to one year. The initi...
Eligibility Criteria
Inclusion
- Male or female
- Between the ages of 13 and 19 years
- Acute sports-related concussion
Exclusion
- Currently following a low carbohydrate (\<100 g/day) diet
- Currently pregnant
- Weight loss greater than or equal to 5% body weight over the last 2 months
- Newly diagnosed and treated (\<6 months) mood disorder (i.e. anxiety, depression) or learning disability (i.e. ADD)
- Diagnosed cardiovascular disease, metabolic disease (type 1 or type 2 diabetes), chronic hepatitis, hepatic steatosis, cirrhosis, or IBS
- Presence of a pacemaker, an implanted defibrillator, or other implanted electronic or metallic devices, shrapnel, or other metal
- Previous history of concussion
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04079907
Start Date
March 20 2020
End Date
April 27 2022
Last Update
May 10 2022
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233