Ketone Supplementation in Adolescents Post-Concussion

NCT ID: NCT04079907

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2022-04-27

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ketone

This arm will receive a supplement with 25g ketone ester. It is a commercially available supplement and will be provided as a standard dose.

Group Type: EXPERIMENTAL

Ketone

Intervention Type: DIETARY_SUPPLEMENT

This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.

Placebo

This arm will receive an isocaloric supplement.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.

Interventions

Ketone

This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Eric P. Plaisance

Associate Professor of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

KAC2019

Identifier Type: -

Identifier Source: org_study_id