Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-09-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental 1

2 capsules of creatine HCl per day

Group Type EXPERIMENTAL

Experimental 1

Intervention Type DIETARY_SUPPLEMENT

Creatine HCl

Experimental 2

2 capsules of inulin HCl per day

Group Type PLACEBO_COMPARATOR

Experimental 2

Intervention Type DIETARY_SUPPLEMENT

Innulin (placebo)

Interventions

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Experimental 1

Creatine HCl

Intervention Type DIETARY_SUPPLEMENT

Experimental 2

Innulin (placebo)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes