Chronic Fatigue Syndrome
Conditions
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 supplement
Placebo
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Multidimensional Fatigue Inventory (MFI) score | Baseline and afetr 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Pain in the locomotive apparatus | Baseline and after 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Daily physical activity | Baseline and after 3 months | Measurement of duration, frequency, and intensity of various types of human physical activity (exercise and nonexercise physical activity) |
| Side-effects prevalence | During 3 months of intervention | — |
| Serum creatine | Baseline and after 3 months | — |
| Muscular strength | 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. |
| Health-related quality of life | Baseline and after 3 months | — |
Countries
Serbia