Creatine Supplementation in Concussion Recovery

Part of paid clinical trials in San Diego, California.

Sponsor
San Diego State University
Study ID
NCT06208813
Status
Recruiting
Apply to this trial

Conditions

  • Concussion, Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Creatine — DIETARY_SUPPLEMENT
    Creatine supplementation

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jun 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    Participants will consume their normal daily diet.
  • Experimental: Creatine supplementation
    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.

Primary Outcome Measure

Days to asymptomatic [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Diego State UniversitySan DiegoCalifornia92812
Michelle L Weber Rawlins, PhD,ATC
[email protected]
619-594-1924

Find similar trials in San Diego, CA

By research site
San Diego State University· San Diego, CA

Related Studies