Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213679
• Other study ID #: 878/13-EUTC:03
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: January 30, 2017
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Center for Health, Exercise and Sport Sciences, Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Dietary Supplement:
• Guanidinoacetic acid
Dietary supplement

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Serbia	Center for Health, Exercise and Sport Sciences	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Center for Health, Exercise and Sport Sciences, Serbia

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life		Baseline and after 3 months
Other	Daily physical activity	Measurement of duration, frequency, and intensity of various types of human physical activity (exercise and nonexercise physical activity)	Baseline and after 3 months
Other	Muscular strength	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
Other	Serum creatine		Baseline and after 3 months
Other	Side-effects prevalence		During 3 months of intervention
Primary	Change in the Multidimensional Fatigue Inventory (MFI) score		Baseline and afetr 3 months
Secondary	Pain in the locomotive apparatus		Baseline and after 3 months