Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

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Giriş / Qeydiyyatdan keçin

Bağlantı panoya saxlanılır

StatusTamamlandı

Sponsorlar

Center for Health, Exercise and Sport Sciences, Serbia

KLINIK SINAQ: NCT02213679

BioSeek: nct02213679

Açar sözlər

Mücərrəd

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.

Təsvir

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.

Tarixlər

Son Doğrulandı:	12/31/2016
İlk təqdim:	08/04/2014
Təxmini qeydiyyat təqdim edildi:	08/06/2014
İlk Göndərmə:	08/10/2014
Son Yeniləmə Göndərildi:	01/29/2017
Son Yeniləmə Göndərildi:	01/31/2017
Həqiqi Təhsilin Başlama Tarixi:	07/31/2014
Təxmini İlkin Tamamlanma Tarixi:	05/31/2015
Təxmini İşin Tamamlanma Tarixi:	06/30/2015

Vəziyyət və ya xəstəlik

Chronic Fatigue Syndrome

Müdaxilə / müalicə

Dietary Supplement: Guanidinoacetic acid

Other: Placebo

Faza

Qol Qrupları

Qol	Müdaxilə / müalicə
Experimental: Guanidinoacetic acid Supplementation with dietary guanidinoacetic acid	Dietary Supplement: Guanidinoacetic acid Dietary supplement
Placebo Comparator: Placebo Supplementation with cellulose	Other: Placebo Placebo

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	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

Nəticə

İlkin nəticə tədbirləri

1. Change in the Multidimensional Fatigue Inventory (MFI) score [Baseline and afetr 3 months]

İkincili Nəticə Tədbirləri

1. Pain in the locomotive apparatus [Baseline and after 3 months]

Digər nəticə tədbirləri

1. Health-related quality of life [Baseline and after 3 months]

2. 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)

3. 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.

4. Serum creatine [Baseline and after 3 months]

5. Side-effects prevalence [During 3 months of intervention]

Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Açar sözlər

fatigue

guanidinoacetic acid

adenosine

adenosine triphosphate

creatine

mantar