Concussion, MildNCT04079907
Ketone Supplementation in Adolescents Post-Concussion
A study testing Ketone in people with Concussion, Mild and Concussion, Severe, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Concussion, Severe, Concussion, Brain
- What is being tested?
- Ketone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female
- Between the ages of 13 and 19 years
- Acute sports-related concussion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Effects of Ketone Supplementation on Functional Outcomes in Adolescents Post-Concussion
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.
Read the 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
- Being tested
- Ketone, Placebo
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneDietary supplement
This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
PlaceboDietary supplement
This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ketone |
| Placebo | Placebo comparator | This arm will receive an isocaloric supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change in MRI from Baseline to 30 days
Serum Analyses
Serum levels of glucose and insulin
Measured: Change in serum levels of glucose and insulin (mg/dL) from Baseline to 14 days to 30 days
Serum Analyses
Serum levels of glutamate
Measured: Change in serum levels of glutamate (µmol/L) from Baseline to 14 days to 30 days
Serum Analyses
Serum levels of lactate and ketones
Measured: 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
Measured: 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
Measured: 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
Progression through the return-to-learn protocol occurs based on the participant's tolerance and will be self-reported. The date each stage is initiated and completed, the total number of days spent in each stage, and the number of attempts needed to complete each stage will be documented on a chart
Measured: Until completion of the protocol, an average of 3 weeks.
Rate of Completion of Return-to-Play Protocol
Progression through the return-to-play protocol will be monitored and documented by athletic trainers at the participant's school once the participant is asymptomatic for at least 48 hours. Initiation and completion dates, number of attempts, symptoms, and post-test Concussion Grading Scales will be recorded by the athletic trainer.
Measured: Until completion of the protocol, an average of 3 weeks.
GI Distress Questionnaire
A questionnaire for five symptoms: nausea, urge to vomit, bloating, belching, and cramps. Participants will be asked to fill out the questionnaire based on their global experience and symptoms throughout the 2-week experimental condition.
Measured: At follow up visit #1 (14 days)
Bioelectrical Impedance Analysis (BIA)
BIA is a non-invasive technique from which total body composition will be measured. Estimates of fat mass, lean mass, total body water, and bone mineral density for the whole body and defined anatomical region (trunk, arms, and legs) will be assessed using the Tanita body composition analyzer.
Measured: The participant will be assessed at baseline (<7 days post-SRC), 14 days, and 30 days
Diet Analysis
At each visit participants will be asked to submit a 24-hour dietary recall. A Registered Dietitian will be on site to ensure completeness and clarity. Data from diet recalls will be entered into diet analysis software and examined for total calories, carbohydrate, protein, fat, and select vitamins related to ketone and brain metabolism. Detailed printouts of nutrient intake will be compared to written entries by another member of the research team to identify errors in entry and ensure accurate data entry.
Measured: 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
Supplement Compliance
Throughout the 2-week supplementation period, participants will be asked to verify the supplement is taken 3 times per day.
Measured: At follow up visit #1 (14 days)
Anthropometrics
Weight and height (measured with a standard stadiometer with heel plate) will be measured to the nearest 0.1 kilograms and 0.1 inches, respectively, in minimal clothing and without shoes and a z-score for body mass index (BMI) percentiles will be calculated according to age- and sex-standards.
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start20 Mar 2020
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric P. Plaisance, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079907
- Sponsor's protocol ID
- KAC2019
- Status last verified
- May 2022
- First submitted
- 17 Jul 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ketone Supplementation on Functional Outcomes in Adolescents Post-Concussion
- ClinicalTrials.gov ID
- NCT04079907
- Acronym / sponsor ID
- KAC2019
- Conditions
- Concussion, Mild, Concussion, Severe, Concussion, Brain, Concussive Injury, Sport Injury, Sports Injuries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketone | Experimental | Dietary Supplement: KetoneThis arm will receive a supplement with 25g ketone ester. It is a commercially available supplement and will be provided as a standard dose. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will receive an isocaloric supplement. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female
- Between the ages of 13 and 19 years
- Acute sports-related concussion
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetoneThis intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits. | Dietary supplement | Ketone |
| PlaceboThis 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 |
Primary outcome
Sport Concussion Assessment Tool (SCAT5)
Time frame: Change in SCAT5 from Baseline to 30 days
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.
C3 Logix System
Time frame: Change in C3 Logix from Baseline to 30 days
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.
Magnetic Resonance Imaging (MRI)
Time frame: Change in MRI from Baseline to 30 days
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.
Serum Analyses
Time frame: Change in serum levels of glucose and insulin (mg/dL) from Baseline to 14 days to 30 days
Serum levels of glucose and insulin
Serum Analyses
Time frame: Change in serum levels of glutamate (µmol/L) from Baseline to 14 days to 30 days
Serum levels of glutamate
Serum Analyses
Time frame: Change in serum levels of lactate and ketones (mmol/L) from Baseline to 14 days to 30 days
Serum levels of lactate and ketones
Serum Analyses
Time frame: Change in serum levels of TNF, IL-6, and IL-10 (pg/mL) from Baseline to 14 days to 30 days
Serum levels of TNF, IL-6, and IL-10
Serum Analyses
Time frame: Change in serum levels of CRP (mg/L) from Baseline to 14 days to 30 days
Serum levels of CRP
7 secondary outcomes
Rate of Completion of Return-to-Learn Protocol
Time frame: Until completion of the protocol, an average of 3 weeks.
Rate of Completion of Return-to-Play Protocol
Time frame: Until completion of the protocol, an average of 3 weeks.
GI Distress Questionnaire
Time frame: At follow up visit #1 (14 days)
Bioelectrical Impedance Analysis (BIA)
Time frame: The participant will be assessed at baseline (<7 days post-SRC), 14 days, and 30 days
Diet Analysis
Time frame: 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
Supplement Compliance
Time frame: At follow up visit #1 (14 days)
Anthropometrics
Time frame: At each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone in people with Concussion, Mild and Concussion, Severe, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sport Concussion Assessment Tool (SCAT5) (time frame: Change in SCAT5 from Baseline to 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.