Influence of CReatine supplementation on mUScle mass and strength after stroke (ICaRUS Stroke Trial): study protocol for a randomized controlled trial.
Study Goal
The researchers aimed to compare the effects of maltodextrin (as a placebo) versus creatine supplementation on functional capacity, strength, and muscle mass changes in stroke patients during hospitalization.
Results Summary
The study did not report specific outcomes for maltodextrin alone, as it was used as a placebo control. The focus was on creatine supplementation, with no adverse effects or significant benefits attributed to maltodextrin.
Population
Individuals with acute ischemic stroke during hospitalization.
Effective Dosage
10g twice daily.
Duration
7 days.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
creatine supplementation | neutral | functional capacity, strength, and changes in muscle mass | individuals with ischemic stroke in the acute phase | - | verify the effectiveness | #1 |
creatine supplementation | neutral | inflammatory profiles | all participants | - | assess | #2 |
creatine supplementation | neutral | functional capacity, muscle strength, mortality, and quality of life | individuals with ischemic stroke in the acute phase | - | verify | #3 |
powdered milk protein serum isolate supplementation | neutral | protein intake | patients with stroke | 1.5g of protein/kg of body weight/day | achieve the goal | #4 |
daily physiotherapy | neutral | - | patients with stroke | - | according to the current rehabilitation guidelines | #5 |
BACKGROUND: Stroke is a leading cause of mortality and disability, and its sequelae are associated with inadequate food intake which can lead to sarcopenia. The aim of this study is to verify the effectiveness of creatine supplementation on functional capacity, strength, and changes in muscle mass during hospitalization for stroke compared to usual care. An exploratory subanalysis will be performed to assess the inflammatory profiles of all participants, in addition to a follow-up 90 days after stroke, to verify functional capacity, muscle strength, mortality, and quality of life. METHODS: Randomized, double-blind, unicenter, parallel-group trial including individuals with ischemic stroke in the acute phase. The duration of the trial for the individual subject will be approximately 90 days, and each subject will attend a maximum of three visits. Clinical, biochemical, anthropometric, body composition, muscle strength, functional capacity, degree of dependence, and quality of life assessments will be performed. Thirty participants will be divided into two groups: intervention (patients will intake one sachet containing 10g of creatine twice a day) and control (patients will intake one sachet containing 10g of placebo [maltodextrin] twice a day). Both groups will receive supplementation with powdered milk protein serum isolate to achieve the goal of 1.5g of protein/kg of body weight/day and daily physiotherapy according to the current rehabilitation guidelines for patients with stroke. Supplementation will be offered during the 7-day hospitalization. The primary outcomes will be functional capacity, strength, and changes in muscle mass after the intervention as assessed by the Modified Rankin Scale, Timed Up and Go test, handgrip strength, 30-s chair stand test, muscle ultrasonography, electrical bioimpedance, and identification of muscle degradation markers by D3-methylhistidine. Follow-up will be performed 90 days after stroke to verify functional capacity, muscle strength, mortality, and quality of life. DISCUSSION: The older population has specific nutrient needs, especially for muscle mass and function maintenance. Considering that stroke is a potentially disabling event that can lead the affected individual to present with numerous sequelae, it is crucial to study the mechanisms of muscle mass loss and understand how adequate supplementation can help these patients to better recover. TRIAL REGISTRATION: The Brazilian Clinical Trials Registry (ReBEC) RBR-9q7gg4 . Registered on 21 January 2019.