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Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02213679
Enrollment
20
Registered
2014-08-11
Start date
2014-08-31
Completion date
2015-07-31
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Keywords

Creatine, Guanidinoacetic acid, Intervention, Fatigue, Muscle strength

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.

Interventions

DIETARY_SUPPLEMENTGuanidinoacetic acid

Dietary supplement

OTHERPlacebo

Placebo

Sponsors

Center for Health Sciences, Serbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in the Multidimensional Fatigue Inventory (MFI) scoreBaseline and afetr 3 months

Secondary

MeasureTime frame
Pain in the locomotive apparatusBaseline and after 3 months

Other

MeasureTime frameDescription
Daily physical activityBaseline and after 3 monthsMeasurement of duration, frequency, and intensity of various types of human physical activity (exercise and nonexercise physical activity)
Side-effects prevalenceDuring 3 months of intervention
Serum creatineBaseline and after 3 months
Muscular strengthBaseline and after 3 monthsFor 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.
Health-related quality of lifeBaseline and after 3 months

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026