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临床试验/NCT02213679
NCT02213679已完成不适用

Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

Center for Health, Exercise and Sport Sciences, Serbia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in the Multidimensional Fatigue Inventory (MFI) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who fulfilled the 1994 CDC criteria for CFS
  • Older than 18 years of age will be candidates for inclusion in the study.

排除标准

  • Psychiatric comorbidity
  • Use of any dietary supplement within 4-weeks prior to the study commencing

结局指标

主要结局

Change in the Multidimensional Fatigue Inventory (MFI) score

时间窗: Baseline and afetr 3 months

次要结局

  • Pain in the locomotive apparatus(Baseline and after 3 months)

研究者

发起方
Center for Health, Exercise and Sport Sciences, Serbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

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

Associate Professor of Biomedical Sciences

Center for Health, Exercise and Sport Sciences, Serbia

研究点 (2)

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