Ketone Supplementation in Adolescents Post-Concussion
Condition: Concussion, Mild; Concussion, Severe; Concussion, Brain; Concussive Injury; Sport Injury; Sports Injuries in Children
MeSH terms: Brain Concussion; Wounds and Injuries; Athletic Injuries
Study type: Interventional

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.
    

Intervention name(s): Ketone; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.; This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into 1 of 2 groups, experimental or placebo control, and will remain in that group for the duration of the study.
Masking: Single (Participant)
Primary purpose: Treatment