NCT04079907

Ketone Supplementation in Adolescents Post-Concussion

Effects of Ketone Supplementation on Functional Outcomes in Adolescents Post-Concussion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Accepted

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 substantial physiological and cognitive ramifications. If not adequately managed, adolescent concussions can have profound long-term effects. The purpose of this study is to determine whether ketone supplementation after a concussion will reduce long-term consequences and improve short-term functional status and outcomes in adolescents who have suffered a concussion.

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 initial visit (pre-experimental visit) will serve to obtain informed consent, anthropometric information, a 24-hour dietary recall, health and lifestyle questionnaire, and circulating metabolites. Randomization will also occur at the initial visit and will be done by a computer to determine each participant's group assignment. Unless otherwise specified, follow up visits (experimental visits) will involve an identical clinical protocol as described below. The following are clinical tests that will be conducted during study visits: Initial Visit: Participants will arrive to the Concussion Clinic in the Sports Medicine Clinic at Children's of Alabama for their routine initial visit. Participants will be provided with the study protocol, the purpose of the study, and routine and potential risks associated with the study procedures. Participants will then fill out the informed consent/assent, health and lifestyle questionnaire, and 24-hour dietary recall. As part of standard of care, height and weight will be measured using a stadiometer, body mass index (BMI) will be calculated, circulating metabolites will be collected, and resting blood pressure will be measured using a standard blood pressure cuff and a stethoscope. The SCAT5 will be conducted by a licensed healthcare professional. For research-specific purposes, body composition will be measured using BIA, C3Logix evaluation will be conducted by trained research personnel, and MRI scans will be taken. Participants will then be randomly assigned to 1 of 2 experimental groups and the appropriate supplement will be provided. Participants will also be provided with information regarding Return-to-Play progression and documents to track Return-to-Learn, supplement compliance, and GI distress. Follow-up Visits: Participants will arrive to the Concussion Clinic in the Sports Medicine Clinic at Children's of Alabama for their routine follow up visits. Participants will fill out the 24-hour dietary recall. As part of standard of care, height and weight will be measured using a stadiometer, body mass index (BMI) will be calculated, circulating metabolites will be collected, and resting blood pressure will be measured using a standard blood pressure cuff and a stethoscope. The SCAT5 will be conducted by a licensed healthcare professional. For research-specific purposes, body composition will be measured using BIA and C3Logix evaluation will be conducted by trained research personnel. Data collection sheets for the Return-to-Learn Progression, supplement compliance, and GI distress will be collected. If applicable, data collection sheets for the Return-to-Play Progression will be collection. Supplement compliance and GI distress will only be collected at follow up visit #1. Return-to-Learn Progression will be evaluated at each visit until completion of the Return-to-Learn Protocol.

Conditions

• Concussion, Mild
• Concussion, Severe
• Concussion, Brain
• Concussive Injury
• Sport Injury
• Sports Injuries in Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone	This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
DIETARY_SUPPLEMENT	Placebo	This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.

Timeline

• Start date: 2020-03-20
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2019-09-06
• Last updated: 2022-05-10

Locations

1 site across 1 country: United States