Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
Study Overview
Brief Summary
Adult patients undergoing chronic dialysis therapy for at least three months were selected. A physical function assessment was conducted, including the Short Physical Performance Battery (SPPB) and a handgrip strength test. Additionally, a bioelectrical impedance analysis was performed. Subsequently, 5 grams of creatine were administered daily for a period of eight weeks, after which the same assessments were repeated. The results were then analyzed to identify any differences in the tests, aiming to detect potential changes following creatine supplementation.
Detailed Description
Adult patients undergoing chronic dialysis therapy for at least three months were selected, primarily based on their good adherence to pharmacological and dialysis treatment regimens. A physical function assessment was conducted, including the Short Physical Performance Battery (SPPB) and a handgrip strength test. Additionally, a bioelectrical impedance analysis was performed.
All participants were informed that creatine would be administered and provided written informed consent. The study protocol was approved by the local ethics committee.
Creatine supplementation consisted of 5 grams per day for eight weeks. On dialysis days, the dose was administered immediately after the dialysis session. On non-dialysis days, patients were responsible for self-administering the creatine at home. The creatine was diluted in 100 mL of water before ingestion.
All assessments were conducted the day following the second dialysis session of the week-on Thursday or Friday, depending on the patient's schedule. There was no control group so pre-creatine measurements were considered as the basal (control) state. Measurements were taken before and after the creatine supplementation period in the same patients. The data were analyzed to evaluate changes in the outcomes following creatine use.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible to provide informed consent
- •At least three months on chronic dialysis therapy
- •No physical impairments that would prevent completion of the SPPB or bioelectrical impedance analysis
Exclusion Criteria
- •Pregnancy
- •Use of any nutritional supplement
Arms & Interventions
Pre creatine and post
patients before and after creatine suplemmentation
Intervention: Creatine (Dietary Supplement)
Outcomes
Primary Outcomes
Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
Time Frame: eigth weeks
To compare the physical functionality status of selected patients, as assessed by the Short Physical Performance Battery (SPPB), before and after eight weeks of creatine supplementation. Scale range between 0-12 points. Higher points mean a better outcome (higher physical functionality).
Secondary Outcomes
- Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: intracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
- Compare body composition: phase angle (degrees), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation(eigth weeks)
Investigators
Carla Basualto Alarcón
Associate Professor, U Aysen. MD., MSc., PhD.
Universidad de Aysén