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Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

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Center for Health, Exercise and Sport Sciences, Serbia

キーワード

概要

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.

説明

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.

日付

最終確認済み: 12/31/2016
最初に提出された: 08/04/2014
提出された推定登録数: 08/06/2014
最初の投稿: 08/10/2014
最終更新が送信されました: 01/29/2017
最終更新日: 01/31/2017
実際の研究開始日: 07/31/2014
一次完了予定日: 05/31/2015
研究完了予定日: 06/30/2015

状態または病気

Chronic Fatigue Syndrome

介入/治療

Dietary Supplement: Guanidinoacetic acid

Other: Placebo

段階

-

アームグループ

介入/治療
Experimental: Guanidinoacetic acid
Supplementation with dietary guanidinoacetic acid
Dietary Supplement: Guanidinoacetic acid
Dietary supplement
Placebo Comparator: Placebo
Supplementation with cellulose
Other: Placebo
Placebo

適格基準

研究の対象となる年齢 18 Years に 18 Years
研究に適格な性別All
健康なボランティアを受け入れるはい
基準

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

結果

主な結果の測定

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

二次的な結果の測定

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

その他の成果対策

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]

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