Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Guanidinoacetic acid
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Fatigue Syndrome focused on measuring Creatine, Guanidinoacetic acid, Intervention, Fatigue, Muscle strength
Eligibility 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
Sites / Locations
- Center for Health, Exercise and Sport Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Guanidinoacetic acid
Placebo
Arm Description
Supplementation with dietary guanidinoacetic acid
Supplementation with cellulose
Outcomes
Primary Outcome Measures
Change in the Multidimensional Fatigue Inventory (MFI) score
Secondary Outcome Measures
Pain in the locomotive apparatus
Full Information
NCT ID
NCT02213679
First Posted
August 5, 2014
Last Updated
January 30, 2017
Sponsor
Center for Health, Exercise and Sport Sciences, Serbia
1. Study Identification
Unique Protocol Identification Number
NCT02213679
Brief Title
Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome
Official Title
Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Health, Exercise and Sport Sciences, Serbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
Creatine, Guanidinoacetic acid, Intervention, Fatigue, Muscle strength
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guanidinoacetic acid
Arm Type
Experimental
Arm Description
Supplementation with dietary guanidinoacetic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Supplementation with cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
Guanidinoacetic acid
Intervention Description
Dietary supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in the Multidimensional Fatigue Inventory (MFI) score
Time Frame
Baseline and afetr 3 months
Secondary Outcome Measure Information:
Title
Pain in the locomotive apparatus
Time Frame
Baseline and after 3 months
Other Pre-specified Outcome Measures:
Title
Health-related quality of life
Time Frame
Baseline and after 3 months
Title
Daily physical activity
Description
Measurement of duration, frequency, and intensity of various types of human physical activity (exercise and nonexercise physical activity)
Time Frame
Baseline and after 3 months
Title
Muscular strength
Description
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.
Time Frame
Baseline and after 3 months
Title
Serum creatine
Time Frame
Baseline and after 3 months
Title
Side-effects prevalence
Time Frame
During 3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergej M Ostojic, MD, PhD
Organizational Affiliation
Faculty of Sport and Physical Education, Novi Sad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health, Exercise and Sport Sciences
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23329885
Citation
Ostojic SM, Niess B, Stojanovic M, Obrenovic M. Creatine metabolism and safety profiles after six-week oral guanidinoacetic acid administration in healthy humans. Int J Med Sci. 2013;10(2):141-7. doi: 10.7150/ijms.5125. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
23351309
Citation
Ostojic SM, Niess B, Stojanovic M, Obrenovic M. Co-administration of methyl donors along with guanidinoacetic acid reduces the incidence of hyperhomocysteinaemia compared with guanidinoacetic acid administration alone. Br J Nutr. 2013 Sep 14;110(5):865-70. doi: 10.1017/S0007114512005879. Epub 2013 Jan 28.
Results Reference
background
PubMed Identifier
24535415
Citation
Ostojic SM, Stojanovic M, Drid P, Hoffman JR. Dose-response effects of oral guanidinoacetic acid on serum creatine, homocysteine and B vitamins levels. Eur J Nutr. 2014 Dec;53(8):1637-43. doi: 10.1007/s00394-014-0669-0. Epub 2014 Feb 18.
Results Reference
background
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Guanidinoacetic Acid Loading for Chronic Fatigue Syndrome
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