Clinical trial NCT04079907: Ketone Supplementation in Adolescents Post-Concussion
Official title: Effects of Ketone Supplementation on Functional Outcomes in Adolescents Post-Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Mild
Concussion, Severe
Concussion, Brain
Concussive Injury
Sport Injury
Sports Injuries in Children
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 5
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Between the ages of 13 and 19 years
* Acute sports-related concussion

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sport Concussion Assessment Tool (SCAT5)
timeFrame: Change in SCAT5 from Baseline to 30 days
measure: C3 Logix System
timeFrame: Change in C3 Logix from Baseline to 30 days
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Change in MRI from Baseline to 30 days
measure: Serum Analyses
timeFrame: Change in serum levels of glucose and insulin (mg/dL) from Baseline to 14 days to 30 days
measure: Serum Analyses
timeFrame: Change in serum levels of glutamate (µmol/L) from Baseline to 14 days to 30 days
measure: Serum Analyses
timeFrame: Change in serum levels of lactate and ketones (mmol/L) from Baseline to 14 days to 30 days
measure: Serum Analyses
timeFrame: Change in serum levels of TNF, IL-6, and IL-10 (pg/mL) from Baseline to 14 days to 30 days
measure: Serum Analyses
timeFrame: Change in serum levels of CRP (mg/L) from Baseline to 14 days to 30 days
Secondary outcomes:
measure: Rate of Completion of Return-to-Learn Protocol
timeFrame: Until completion of the protocol, an average of 3 weeks.
measure: Rate of Completion of Return-to-Play Protocol
timeFrame: Until completion of the protocol, an average of 3 weeks.
measure: GI Distress Questionnaire
timeFrame: At follow up visit #1 (14 days)
measure: Bioelectrical Impedance Analysis (BIA)
timeFrame: The participant will be assessed at baseline (<7 days post-SRC), 14 days, and 30 days
measure: Diet Analysis
timeFrame: Immediately after concussion, at first clinic visit (within 7 days after concussion), 14 days after initial visit, 30 days after initial visit, and at each follow up visit up to 1 year
measure: Supplement Compliance
timeFrame: At follow up visit #1 (14 days)
measure: Anthropometrics
timeFrame: At each visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: