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Trial record 11 of 112 for:    Chronic Fatigue Syndrome

Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome

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ClinicalTrials.gov Identifier: NCT02213679
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia

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.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Dietary Supplement: Guanidinoacetic acid Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guanidinoacetic acid
Supplementation with dietary guanidinoacetic acid
Dietary Supplement: Guanidinoacetic acid
Dietary supplement

Placebo Comparator: Placebo
Supplementation with cellulose
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Change in the Multidimensional Fatigue Inventory (MFI) score [ Time Frame: Baseline and afetr 3 months ]

Secondary Outcome Measures :
  1. Pain in the locomotive apparatus [ Time Frame: Baseline and after 3 months ]

Other Outcome Measures:
  1. Health-related quality of life [ Time Frame: Baseline and after 3 months ]
  2. Daily physical activity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and after 3 months ]
  5. Side-effects prevalence [ Time Frame: During 3 months of intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213679


Locations
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Serbia
Center for Health, Exercise and Sport Sciences
Belgrade, Serbia, 11000
Sponsors and Collaborators
Center for Health, Exercise and Sport Sciences, Serbia
Investigators
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Principal Investigator: Sergej M Ostojic, MD, PhD Faculty of Sport and Physical Education, Novi Sad

Publications:
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Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Associate Professor of Biomedical Sciences, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier: NCT02213679     History of Changes
Other Study ID Numbers: 878/13-EUTC:03
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia:
Creatine
Guanidinoacetic acid
Intervention
Fatigue
Muscle strength
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs