Effects of Ketone Supplementation on Functional Outcomes in Adolescents Post-Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Sport Concussion Assessment Tool (SCAT5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be aware if the supplement they receive is the experimental supplement or the placebo control
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Between the ages of 13 and 19 years
- •Acute sports-related concussion
排除标准
- •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
结局指标
主要结局
Sport Concussion Assessment Tool (SCAT5)
时间窗: 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.
Serum Analyses
时间窗: Change in serum levels of CRP (mg/L) from Baseline to 14 days to 30 days
Serum levels of CRP
C3 Logix System
时间窗: 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)
时间窗: 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.
次要结局
- Rate of Completion of Return-to-Learn Protocol(Until completion of the protocol, an average of 3 weeks.)
- Bioelectrical Impedance Analysis (BIA)(The participant will be assessed at baseline (<7 days post-SRC), 14 days, and 30 days)
- Supplement Compliance(At follow up visit #1 (14 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)
- 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))
- Anthropometrics(At each visit)
研究者
Eric P. Plaisance
Associate Professor of Kinesiology
University of Alabama at Birmingham