Effect of Supplementation With Creatine on the Recovery of Ischemic Stroke

NCT06576466 | Recruiting

• 1 other identifier: PROSALUT2023-27
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic

Keywords

stroke; creatine; sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months, 6 months

Secondary Outcomes (19)

• Physical performance using Test "timed up and go" (TUG).

  3 months, 6 months

• Maximum muscle strength

  3 months, 6 months

• Arm and leg muscle strength

  3 months, 6 months

• Balance and stability

  3 months, 6 months

• Functional impact

  3 months, 6 months

Study Arms (2)

Creatine monohydrate

EXPERIMENTAL

Creatine monohydrate. Guinama brand with CE marking. Code 89823.

Dietary Supplement: Creatine monohydrate

Dextromaltose

PLACEBO COMPARATOR

Dextrinomaltose. Guinama brand with CE marking. Code 91146.

Other: Placebo

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

Creatine monohydrate. Guinama brand with CE marking. Code 89823.

Creatine monohydrate

Placebo OTHER

Dextrinomaltose. Guinama brand with CE marking. Code 91146.

Dextromaltose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• 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.

You may not qualify if:

• Moderate-severe disability prior to stroke, defined by an mRS\>2.
• 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.

Sponsors & Collaborators

• Fundació d'investigació Sanitària de les Illes Balears: lead
• Comunidad Autónoma de las Islas Baleares (Dirección General de Investigación en Salud, Formación y Acreditación): collaborator

Study Sites (1)

IdISBa

Palma de Mallorca, Balearic Islands, 07120, Spain

RECRUITING

Related Publications (14)

• 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.

  PMID: 19083405 BACKGROUND

• 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.

  PMID: 20976468 BACKGROUND

• 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.

  PMID: 17185404 BACKGROUND

• 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.

  PMID: 17828627 BACKGROUND

• 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.

  PMID: 25632150 BACKGROUND

• 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.

  PMID: 35992184 BACKGROUND

• 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.

  PMID: 35267907 BACKGROUND

• 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.

  PMID: 28572496 BACKGROUND

• 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.

  PMID: 11740307 BACKGROUND

• 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.

  PMID: 24231058 BACKGROUND

• 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.

  PMID: 29116473 BACKGROUND

• Balestrino M. Role of Creatine in the Heart: Health and Disease. Nutrients. 2021 Apr 7;13(4):1215. doi: 10.3390/nu13041215.

  PMID: 33917009 BACKGROUND

• 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.

  PMID: 21508208 BACKGROUND

• 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.

  PMID: 36056731 BACKGROUND

Related Links

• Stroke among top 10 causes of death according to the Word Health Organization (WHO).

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Sarcopenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Raquel Delgado Mederos, PhD

  Fundació d'investigació Sanitària de les Illes Balears

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Delgado Mederos, PhD

CONTACT

0034971205234; raquel.delgado@ssib.es

Eduard Bargay Pizarro, MD

CONTACT

34 971 20 52 34; eduard.bargay@ssib.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A professional from the pharmacy service, who will not be involved in data collection or participant care, will handle the blinding. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers. Data will be shared subject to acceptance by the research team.

Locations

ES (1)