An interventional study of Creatine monohydrate and Placebo in Stroke, Ischemic, sponsored by Fundació d'investigació Sanitària de les Illes Balears. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Fundació d'investigació Sanitària de les Illes Balears · Not applicable, Interventional, and Treatment
Stroke is a leading cause of disability and the second leading cause of death worldwide. Most strokes are ischemic, caused by acute arterial occlusion. Post-stroke treatment focuses on secondary prevention and rehabilitation, but few treatments address functional recovery. Creatine, a supplement known for improving physical performance, may aid in the recovery of stroke patients, reducing sarcopenia and improving strength among other effects. This pilot study will investigate the effectiveness of creatine supplementation in enhancing physical and functional recovery in ischemic stroke patients. The study will involve a randomized, double-blind clinical trial comparing creatine monohydrate to a placebo.
Stroke is one of the most impactful health conditions worldwide, currently being the leading cause of disability and the second leading cause of death globally. Approximately 85-90% of strokes are ischemic, primarily caused by acute arterial occlusion, leading to an area of cerebral, spinal, or retinal infarction. The size of the lesion depends on the affected blood vessel and the duration of the occlusion, as well as cerebral autoregulation, blood pressure, blood sugar levels, and many other factors. After the acute phase, treatment is based on secondary prevention and rehabilitation, with few treatments currently available that focus on functional recovery once the infarction has occurred. Stroke survivors experience a loss of functionality, a decline in physical capacity associated with a decrease in muscle mass, sarcopenia, cognitive impairment, and an increase in anxiety and depressive symptoms.
Creatine is a widely studied nutritional supplement, mainly in athletes, where it has been shown to improve training adaptation and physical performance. Its effects on energy metabolism, as an anti-inflammatory, and on calcium homeostasis have been described. There are also studies indicating possible musculoskeletal benefits in the elderly population. Given its role in improving physical performance and muscle mass, considering the significant impact of these conditions on patients who have suffered an ischemic stroke, and considering its antioxidant and anti-inflammatory effects, we propose a pilot study to determine the effectiveness of creatine supplementation in stroke patients. This supplementation could potentially lead to greater physical and functional recovery following an ischemic stroke.
A randomized, double-blind clinical trial will be conducted. The trial will include a group supplemented with creatine monohydrate at a dose of 0.3 g/kg/day for 7 days, followed by 0.1 g/kg/day for 12 weeks, alongside standard clinical practice; and a control group supplemented with a placebo (corn starch maltodextrin), following the same protocol and doses.
Exclusion Criteria:
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
Dietary Supplement: Creatine monohydrate
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Other: Placebo
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Physical performance
To analyze the improvement in physical performance, at 3 months (at the end of the intervention) and at 6 months, measured by the 6-Minute Walking Test (6MW).
Time frame: 3 months, 6 months
Physical performance using Test "timed up and go" (TUG).
Test "timed up and go" (TUG).
Time frame: 3 months, 6 months
Maximum muscle strength
Maximum muscle strength, measured by manual dynamometer (Kilograms). Grip strength, biceps, triceps, deltoids, psoas, quadriceps and hamstrings will be assessed.
Time frame: 3 months, 6 months
Arm and leg muscle strength
Measured by the score on items 5 and 6 of the National institute of Health Stroke Scale (NIHSS) where the score range is from 0 to 4. A higher score corresponds to a worse performance.
Time frame: 3 months, 6 months
Balance and stability
Balance and stability measured using the Postural Assessment Scale for Stroke Patients (PASS). The scale includes 12 items, which are divided into two categories: maintaining a posture (static balance) and changing a posture (dynamic balance). Higher scores indicate better postural control and balance.
Time frame: 3 months, 6 months
Functional impact
Functional impact measured by the Modified Rankin Scale (mRS). The mRS is a commonly used scale to measure the degree of disability or dependence in daily activities of people who have suffered a stroke. The mRS is scored on a scale from 0 to 6, with higher scores indicating greater disability
Time frame: 3 months, 6 months
Performance in basic activities of daily living
Barthel Scale. The Barthel Index is a scale used to measure a person's performance in basic activities of daily living (ADLs) and assess functional independence
Time frame: 3 and 6 months
Cognitive assessment
Cognitive assessment using the Montreal cognitive assessment (MoCA) test. The MoCA is a tool used to assess cognitive impairment in various domains, including memory, attention, language, and executive function. A higher score means a better outcome.
Time frame: 3 months
Quality of life measured by EuroQol 5D
Quality of life assessment using the "EuroQol 5D". EuroQoL 5D is a standardized tool used to assess health-related quality of life. A higher score corresponds to worse quality of life.
Time frame: 3 months, 6 months
Anxiety and depression symptoms
Assessment of anxiety and depression symptoms using the HADS (Hospital Anxiety and Depression Scale). Both the Anxiety subscale and the Depression subscale range from 0 to 21. Higher scores on either subscale indicate worse outcomes (more severe anxiety or depression).
Time frame: 3 months
Appendicular skeletal muscle mass
Measurement of appendicular (arms and legs) skeletal muscle mass change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A higher skeletal muscle mass means a better outcome.
Time frame: 3 months
Total skeletal muscle mass
Measurement of total skeletal muscle mass change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A higher skeletal muscle mass means a better outcome.
Time frame: 3 months
Appendicular body fat
Measurement of appendicular (arms and legs) and total body fat change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A lower fat mass means a better outcome.
Time frame: 3 months
Total body fat
Measurement of total body fat change from baseline, using DXA (dual-energy X-ray absorptiometry) measured in kilograms. A lower fat mass means a better outcome.
Time frame: 3 months
Nutritional status
Measurement of nutritional status change by phase angle using a bioelectrical impedance analysis. A higher phase angle means a better outcome. Outcome units are degrees.
Time frame: 3 months, 6 months
Number of falls.
Number of falls since last visit.
Time frame: 3 months, 6 months
Geriatric Nutritional Risk Index (GNRI) score
Geriatric Nutritional Risk Index (GNRI) score. The following formula is used: \[1.489 × serum albumin (g/L)\] + (41.7 × weight (kg)/ideal weight (kg)).
Time frame: 3 months, 6 months
Ventricular strain change
Effect of creatine on cardiac damage secondary to stroke measured using ventricular strain measurement (percentage). A lower strain corresponds to a worse outcome.
Time frame: 3 months
Ejection fraction change
Effect of creatine on cardiac damage secondary to stroke measured using ejection fraction (EF) measurement (percentage). A lower EF corresponds to a worse outcome.
Time frame: 3 months
Adverse events
To assess the occurrence of any adverse events in any of the intervention groups.
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in Creatine supplementation and stroke. Data will be shared subject to acceptance by the research team. Data or samples shared will be coded.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Fundació d'investigació Sanitària de les Illes Balears