Creatine Supplementation in Chronic Fatigue Syndrome

Not Applicable

Active, not recruiting

• Conditions: Chronic Fatigue Syndrome
• Interventions: Dietary Supplement: Creatine; Other: Placebo

• Registration Number: NCT02374112
• Lead Sponsor: Center for Health, Exercise and Sport Sciences, Serbia

Brief Summary

This study evaluates the effectiveness of medium-term supplementation with creatine to improve clinical outcomes in well-defined adult CFS population. Half of the participants will receive creatine while the other half will receive placebo.

Detailed Description

Chronic fatigue syndrome (CFS) is a debilitating and complex condition characterized by profound fatigue of unknown cause, which is permanent and limits the person's functional capacity, producing various degrees of disability. It seems that inadequate or impaired energy provision through cellular metabolism may contribute to the pathogenic initiation and maintenance of CFS.

A variety of dietary interventions have been used in the management of CFS, yet no therapeutic modality demonstrated overall positive results in terms of effectiveness. Previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings that do not support the use of a broad-spectrum nutritional supplement in treating CFS-related symptoms. Considering the fact that patients with CFS have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate), effective dietary treatment of CFS should be focused on providing compounds that facilitates cellular bioenergetics. Besides other candidate agents, creatine (Cr) could be of particular interest since it occurs naturally in the human body.

Placebo-controlled, randomized, double-blind, cross-over clinical trial examining the effectiveness of Cr for the treatment of CFS will be organized according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Study Timeline

• Study First Submitted: 2015-02-22
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-27
• Study Start: 2016-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• older than 18 years
• fulfilled CDC criteria for CFS

Exclusion Criteria

• psychiatric co-morbidity
• use of dietary supplement within 4-weeks prior to the study commencing
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Creatine	Creatine supplementation
Control	Placebo	Placebo supplementation

Primary Outcome Measures

Name	Time	Method
Multidimensional Fatigue Inventory (MFI) score	3 months

Secondary Outcome Measures

Name	Time	Method
health-related quality of life	3 months