Ketone Supplementation in Adolescents Post-Concussion

NCT04079907 | Completed

• 1 other identifier: KAC2019
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Sport Concussion Assessment Tool (SCAT5)

  SCAT5 is a standardized tool, not a diagnostic tool, physicians can use for assessing concussions. It will be conducted by a licensed healthcare professional as part of standard of care to obtain numerical values for the following: immediate or on-field assessment (red flags, accident details, etc.), symptom evaluation (dizziness, headache, etc.), cognitive screen (memory, concentration), and neurological screen (balance, coordination). This will be conducted when the concussion occurs and at each clinic visit, irrespective of how much time has passed since the concussion.

  Change in SCAT5 from Baseline to 30 days

• C3 Logix System

  The computer-based system includes the Graded Symptoms Checklist and Neurological Evaluations. This system is used to assess baseline neurological responses. For assessment, a belt with an iPad holder is affixed to the participant's waist and an iPad is clipped in. Neuro-motor function, balance, and vestibular function are evaluated visual acuity and information processing are assessed. It takes an average of 12 minutes for each athlete to complete the assessment.

  Change in C3 Logix from Baseline to 30 days

• Magnetic Resonance Imaging (MRI)

  MRI is a noninvasive, routine diagnostic imaging modality that uses a large magnet, radio waves and a computer to produce 2- and 3-dimensional images of the brain. The adolescent will be placed head first into a cylindrical machine that houses a large, tube-shaped magnet that provides a strong magnetic field, so that a radiofrequency coil can image the brain. The magnetic field, along with applied radiofrequency waves, temporarily alters the alignment of hydrogen protons found in water molecules within the body. Computers construct the images based on the radiofrequency signals emitted by the protons.

  Change in MRI from Baseline to 30 days

• Serum Analyses

  Serum levels of glucose and insulin

  Change in serum levels of glucose and insulin (mg/dL) from Baseline to 14 days to 30 days

• Serum Analyses

  Serum levels of glutamate

  Change in serum levels of glutamate (µmol/L) from Baseline to 14 days to 30 days

• Serum Analyses

  Serum levels of lactate and ketones

  Change in serum levels of lactate and ketones (mmol/L) from Baseline to 14 days to 30 days

• Serum Analyses

  Serum levels of TNF, IL-6, and IL-10

  Change in serum levels of TNF, IL-6, and IL-10 (pg/mL) from Baseline to 14 days to 30 days

• Serum Analyses

  Serum levels of CRP

  Change in serum levels of CRP (mg/L) from Baseline to 14 days to 30 days

Secondary Outcomes (7)

• Rate of Completion of Return-to-Learn Protocol

  Until completion of the protocol, an average of 3 weeks.

• Rate of Completion of Return-to-Play Protocol

  Until completion of the protocol, an average of 3 weeks.

• GI Distress Questionnaire

  At follow up visit #1 (14 days)

• Bioelectrical Impedance Analysis (BIA)

  The participant will be assessed at baseline (<7 days post-SRC), 14 days, and 30 days

• Diet Analysis

  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

Study Arms (2)

Ketone

EXPERIMENTAL

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

Dietary Supplement: Ketone

Placebo

PLACEBO COMPARATOR

This arm will receive an isocaloric supplement.

Dietary Supplement: Placebo

Interventions

Ketone 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.

Ketone

Placebo 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

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Ketones

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware if the supplement they receive is the experimental supplement or the placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Kinesiology

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: September 6, 2019
• Study Start: March 20, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)