Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study (SARCOPA)

Center for Health Sciences, Serbia

Status: Enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: Experimental 2; Dietary Supplement: Experimental 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07285226

4005-31-01

Details and patient eligibility

About

The CONCRET-SARCOPA trial is a 12-week, double-blind, randomized controlled study designed to evaluate the efficacy of creatine HCl supplementation in older adults with sarcopenia. The trial investigates whether daily creatine HCl improves body composition, enhances functional muscle and cognitive performance, and favorably alters key blood biomarkers associated with muscle health and metabolic status. Additionally, the study assesses changes in tissue creatine levels using non-invasive and biochemical methods to clarify mechanistic responses to supplementation. Findings from this trial will provide critical evidence on the therapeutic potential of creatine HCl as a targeted nutritional strategy for managing sarcopenia in the geriatric population.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 60 years
• Low muscle strength by handgrip (SDOC criteria for sarcopenia): < 35.5 kg in men and < 20 kg in women
• Sign free and informed consent
• Demonstrate interest, conditions and availability to participate

Exclusion criteria

• Patients undergoing interventional treatment for sarcopenia
• Physical amputation
• Cognitive impairment (MSSE < 25)
• Unwillingness to return for follow-up analysis
• Participation in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

2 capsules of creatine HCl per day

Treatment:

Dietary Supplement: Experimental 1

Experimental 2

Placebo Comparator group

Description:

2 capsules of inulin HCl per day

Treatment:

Dietary Supplement: Experimental 2