Effect of Supplementation With Creatine on the Recovery of Ischemic Stroke
NCT ID: NCT06576466
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
92 participants
INTERVENTIONAL
2024-09-27
2027-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The care staff responsible for patient care will be unaware of each participant's assignment group.
Blinding may be broken if a serious adverse effect related to the supplementation is suspected in one of the participants.
Study Groups
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Creatine monohydrate
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
Creatine monohydrate
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
Dextromaltose
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Placebo
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Interventions
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Creatine monohydrate
Creatine monohydrate. Guinama brand with CE marking. Code 89823.
Placebo
Dextrinomaltose. Guinama brand with CE marking. Code 91146.
Eligibility Criteria
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Inclusion Criteria
* Recent diagnosis of ischemic stroke (from 24 hours to 5 days) .
* Neurological deficit due to the stroke that affects mobility (paresis and/or ataxia) and requires motor rehabilitation.
* Ability to understand and sign the informed consent form, or failing that, have sufficient support to carry out the correct follow-up of the study.
Exclusion Criteria
* Unstable or severe clinical situation that prevents active rehabilitation.
* Neurological deficit due to stroke that prevents walking without help from another person. The use of support with a cane, crutch or walker is permitted.
* Moderate or severe dysphagia that makes therapeutic adherence difficult.
* Use of creatine supplements in the last 3 months, or use of anabolic products in the last 3 months.
* Severe kidney disease (GFR \<30ml/min/1.73 m2).
* Musculoskeletal pathology that prevents assessment of muscle strength. For example: fractures, severe osteoarthritis, ligament tears or tendinopathies.
* History of allergic reactions to creatine.
* Pregnancy or breastfeeding.
* Simultaneous participation in another clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Comunidad Autónoma de las Islas Baleares (Dirección General de Investigación en Salud, Formación y Acreditación)
UNKNOWN
Fundació d'investigació Sanitària de les Illes Balears
OTHER_GOV
Responsible Party
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Principal Investigators
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Raquel Delgado Mederos, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació d'investigació Sanitària de les Illes Balears
Locations
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IdISBa
Palma de Mallorca, Balearic Islands, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Bender A, Samtleben W, Elstner M, Klopstock T. Long-term creatine supplementation is safe in aged patients with Parkinson disease. Nutr Res. 2008 Mar;28(3):172-8. doi: 10.1016/j.nutres.2008.01.001.
Gualano B, de Salles Painelli V, Roschel H, Lugaresi R, Dorea E, Artioli GG, Lima FR, da Silva ME, Cunha MR, Seguro AC, Shimizu MH, Otaduy MC, Sapienza MT, da Costa Leite C, Bonfa E, Lancha Junior AH. Creatine supplementation does not impair kidney function in type 2 diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial. Eur J Appl Physiol. 2011 May;111(5):749-56. doi: 10.1007/s00421-010-1676-3. Epub 2010 Oct 26.
Pan JW, Takahashi K. Cerebral energetic effects of creatine supplementation in humans. Am J Physiol Regul Integr Comp Physiol. 2007 Apr;292(4):R1745-50. doi: 10.1152/ajpregu.00717.2006. Epub 2006 Dec 21.
McMorris T, Mielcarz G, Harris RC, Swain JP, Howard A. Creatine supplementation and cognitive performance in elderly individuals. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2007 Sep;14(5):517-28. doi: 10.1080/13825580600788100.
Turner CE, Byblow WD, Gant N. Creatine supplementation enhances corticomotor excitability and cognitive performance during oxygen deprivation. J Neurosci. 2015 Jan 28;35(4):1773-80. doi: 10.1523/JNEUROSCI.3113-14.2015.
Butchart S, Candow DG, Forbes SC, Mang CS, Gordon JJ, Ko J, Deprez D, Chilibeck PD, Ditor DS. Effects of Creatine Supplementation and Progressive Resistance Training in Stroke Survivors. Int J Exerc Sci. 2022 Aug 1;15(2):1117-1132. doi: 10.70252/EKHJ1489. eCollection 2022.
Forbes SC, Cordingley DM, Cornish SM, Gualano B, Roschel H, Ostojic SM, Rawson ES, Roy BD, Prokopidis K, Giannos P, Candow DG. Effects of Creatine Supplementation on Brain Function and Health. Nutrients. 2022 Feb 22;14(5):921. doi: 10.3390/nu14050921.
Solis MY, Artioli GG, Otaduy MCG, Leite CDC, Arruda W, Veiga RR, Gualano B. Effect of age, diet, and tissue type on PCr response to creatine supplementation. J Appl Physiol (1985). 2017 Aug 1;123(2):407-414. doi: 10.1152/japplphysiol.00248.2017. Epub 2017 Jun 1.
Chrusch MJ, Chilibeck PD, Chad KE, Davison KS, Burke DG. Creatine supplementation combined with resistance training in older men. Med Sci Sports Exerc. 2001 Dec;33(12):2111-7. doi: 10.1097/00005768-200112000-00021.
Scherbakov N, von Haehling S, Anker SD, Dirnagl U, Doehner W. Stroke induced Sarcopenia: muscle wasting and disability after stroke. Int J Cardiol. 2013 Dec 10;170(2):89-94. doi: 10.1016/j.ijcard.2013.10.031. Epub 2013 Oct 14.
Coleman ER, Moudgal R, Lang K, Hyacinth HI, Awosika OO, Kissela BM, Feng W. Early Rehabilitation After Stroke: a Narrative Review. Curr Atheroscler Rep. 2017 Nov 7;19(12):59. doi: 10.1007/s11883-017-0686-6.
Balestrino M. Role of Creatine in the Heart: Health and Disease. Nutrients. 2021 Apr 7;13(4):1215. doi: 10.3390/nu13041215.
Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.
Scheitz JF, Sposato LA, Schulz-Menger J, Nolte CH, Backs J, Endres M. Stroke-Heart Syndrome: Recent Advances and Challenges. J Am Heart Assoc. 2022 Sep 6;11(17):e026528. doi: 10.1161/JAHA.122.026528. Epub 2022 Sep 3.
Related Links
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Stroke among top 10 causes of death according to the Word Health Organization (WHO).
Other Identifiers
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PROSALUT2023-27
Identifier Type: -
Identifier Source: org_study_id
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