Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

January 30, 2017 updated by: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
Chronic fatigue syndrome (CFS) is a debilitating condition of unknown etiology. Recent studies have shown that CFS is associated with impaired cellular energetics and low levels of phosphocreatine. Since guanidinoacetic acid (GAA) acts as a highly bioavailable precursor of creatine it may provide an ideal dietary supplement to facilitate treatment and perhaps prevention of CFS. The overall hypothesis to be evaluated is that medium-term supplementation with GAA will improve clinical outcomes in well-defined adult CFS patients via augmented provision of creatine. Specific aims: (1) To determine the effects of GAA on CFS symptomatology using a fatigue severity inventory, soreness of locomotive apparatus scales, and a health-related quality of life survey; (2) To determine the effect of GAA on creatine metabolism using laboratory studies and magnetic resonance spectroscopy; (3) To characterize the physiological effects of GAA on work capacity via actigraphy and exercise performance tests; and (4); To determine the prevalence of subjectively reported side-effects and biochemical adverse events associated with GAA intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Whiting et al. 2001). Previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings do not support the use of a broad-spectrum nutritional supplement in treating CFS-related symptoms (Brouwers et al. 2002). Considering the fact that patients with CFS have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate) (Block et al. 1998), effective dietary treatment of CFS should be focused on providing compounds that facilitates cellular bioenergetics. Besides other candidate agents, guanidinoacetic acid (GAA) could be of particular interest since it occurs naturally in the human body and acts as an immediate precursor of creatine (Wyss and Kaddurah-Daouk, 2000). Due to its low cost and high bioavailability (Baker 2009), if proven effective dietary GAA may be suitable for use in broad CFS population.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Center for Health, Exercise and Sport Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults who fulfilled the 1994 CDC criteria for CFS
  • Older than 18 years of age will be candidates for inclusion in the study.

Exclusion Criteria:

  • Psychiatric comorbidity
  • Use of any dietary supplement within 4-weeks prior to the study commencing
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guanidinoacetic acid
Supplementation with dietary guanidinoacetic acid
Dietary supplement: Guanidinoacetic acid
Dietary supplement
Placebo Comparator: Placebo
Supplementation with cellulose
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Multidimensional Fatigue Inventory (MFI) score
Time Frame: Baseline and afetr 3 months
Baseline and afetr 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain in the locomotive apparatus
Time Frame: Baseline and after 3 months
Baseline and after 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: Baseline and after 3 months
Baseline and after 3 months
Daily physical activity
Time Frame: Baseline and after 3 months
Measurement of duration, frequency, and intensity of various types of human physical activity (exercise and nonexercise physical activity)
Baseline and after 3 months
Muscular strength
Time Frame: Baseline and after 3 months
For muscular performance, maximal voluntary strength of knee extensor muscles will be measured bilaterally using an isometric dynamometer during static knee joint movement with leg at 165º of flexion (180º = leg fully extended). The better of two efforts for each leg will be recorded with cumulative value presented as total isometric strength.
Baseline and after 3 months
Serum creatine
Time Frame: Baseline and after 3 months
Baseline and after 3 months
Side-effects prevalence
Time Frame: During 3 months of intervention
During 3 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Health, Exercise and Sport Sciences, Serbia

Investigators

  • Principal Investigator: Sergej M Ostojic, MD, PhD, Faculty of Sport and Physical Education, Novi Sad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 878/13-EUTC:03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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