Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

NCT ID: NCT02213679

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Guanidinoacetic acid

Supplementation with dietary guanidinoacetic acid

Group Type: EXPERIMENTAL

Guanidinoacetic acid

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement

Placebo

Supplementation with cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Guanidinoacetic acid

Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Health Sciences, Serbia

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. Sergej M. Ostojic, MD, PhD

Associate Professor of Biomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergej M Ostojic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Sport and Physical Education, Novi Sad

Locations

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, Serbia

Countries

Serbia

References

Ostojic SM, Niess B, Stojanovic M, Obrenovic M. Creatine metabolism and safety profiles after six-week oral guanidinoacetic acid administration in healthy humans. Int J Med Sci. 2013;10(2):141-7. doi: 10.7150/ijms.5125. Epub 2013 Jan 3.

Reference Type: BACKGROUND

PMID: 23329885 (View on PubMed)

Ostojic SM, Niess B, Stojanovic M, Obrenovic M. Co-administration of methyl donors along with guanidinoacetic acid reduces the incidence of hyperhomocysteinaemia compared with guanidinoacetic acid administration alone. Br J Nutr. 2013 Sep 14;110(5):865-70. doi: 10.1017/S0007114512005879. Epub 2013 Jan 28.

Reference Type: BACKGROUND

PMID: 23351309 (View on PubMed)

Ostojic SM, Stojanovic M, Drid P, Hoffman JR. Dose-response effects of oral guanidinoacetic acid on serum creatine, homocysteine and B vitamins levels. Eur J Nutr. 2014 Dec;53(8):1637-43. doi: 10.1007/s00394-014-0669-0. Epub 2014 Feb 18.

Reference Type: BACKGROUND

PMID: 24535415 (View on PubMed)

Other Identifiers

878/13-EUTC:03

Identifier Type: -

Identifier Source: org_study_id