Creatine Supplementation in Concussion Recovery

NCT06208813 | Recruiting

• 1 other identifier: Temp-4061
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to compare concussion recovery in those supplementing creatine and those not supplementing creatine. Specific aim 1: To compare number of days until asymptomatic between those taking creatine vs. those not taking creatine following a concussion. Hypothesis: The investigators hypothesize that individuals taking creatine will become asymptomatic sooner than those not taking creatine.Specific aim 2: To compare typical concussion assessment scores (i.e., symptom score, mental status, neurocognition, balance, motor coordination, and visual performance) between those taking creatine vs those not taking creatine following a concussion once asymptomatic.Hypothesis: The investigators hypothesize that individuals taking creatine will have better symptom scores, balance, mental status, and neurocognition assessment scores than those not taking creatine once asymptomatic. The investigators will calculate descriptive statistics for all demographic, days to asymptomatic, and concussion assessments. For specific aim 1, The investigators will calculate a t-test to determine if days to asymptomatic differed in those taking creatine vs. those not taking creatine. For specific aim 2, the investigators will calculate t-tests with Bonferonni corrections to determine if concussion assessment scores (Sport Concussion Office Assessment Tool-6 assessments, CNS Vital Signs, visual assessment) differed in those taking creatine vs. those not taking creatine.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• Days to asymptomatic

  Days to asymptomatic

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

Secondary Outcomes (30)

• Symptom evaluation - Sport Concussion Office Assessment Tool 6

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

• Standardized Assessment of Concussion - Sport Concussion Office Assessment Tool 6

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

• Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

• Orthostatic Vital Signs - Sport Concussion Office Assessment Tool 6

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

• Balance Error Scoring System - Sport Concussion Office Assessment Tool 6

  From date of injury until the date in which symptoms are no longer experienced as measured by a symptom assessment, assessed up to 100 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Participants will consume their normal daily diet.

Creatine supplementation

EXPERIMENTAL

The intervention group will consume their usual diet plus 5 grams of creatine for the first four days following the initial meeting, and then 3 grams of creatine once per day thereafter until asymptomatic.

Dietary Supplement: Creatine

Interventions

Creatine DIETARY_SUPPLEMENT

Creatine supplementation

Creatine supplementation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old with a diagnosed concussion within 72 hours post-injury

You may not qualify if:

• Learning disability, renal disease, mental behavior or migraine history, and current creatine use or have not taken creatine in the past 6 weeks

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Diego State University

San Diego, California, 92812, United States

RECRUITING

Related Publications (4)

• Roschel H, Gualano B, Ostojic SM, Rawson ES. Creatine Supplementation and Brain Health. Nutrients. 2021 Feb 10;13(2):586. doi: 10.3390/nu13020586.

  PMID: 33578876 BACKGROUND

• Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.

  PMID: 24601910 RESULT

• Giza CC, Hovda DA. The new neurometabolic cascade of concussion. Neurosurgery. 2014 Oct;75 Suppl 4(0 4):S24-33. doi: 10.1227/NEU.0000000000000505.

  PMID: 25232881 RESULT

• Harmon KG, Clugston JR, Dec K, Hainline B, Herring S, Kane SF, Kontos AP, Leddy JJ, McCrea M, Poddar SK, Putukian M, Wilson JC, Roberts WO. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019 Feb;53(4):213-225. doi: 10.1136/bjsports-2018-100338.

  PMID: 30705232 RESULT

MeSH Terms

Conditions

Brain Concussion

Interventions

Creatine

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)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michelle Weber Rawlins

  San Diego State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Weber Rawlins, PhD, ATC

CONTACT

619-594-1924; mrawlins@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: January 17, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)