NCT02213679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

August 5, 2014

Last Update Submit

January 30, 2017

Conditions

Chronic Fatigue Syndrome

Keywords

CreatineGuanidinoacetic acidInterventionFatigueMuscle strength

Outcome Measures

Primary Outcomes (1)

  • Change in the Multidimensional Fatigue Inventory (MFI) score

    Baseline and afetr 3 months

Secondary Outcomes (1)

  • Pain in the locomotive apparatus

    Baseline and after 3 months

Other Outcomes (5)

  • Health-related quality of life

    Baseline and after 3 months

  • Daily physical activity

    Baseline and after 3 months

  • Muscular strength

    Baseline and after 3 months

  • +2 more other outcomes

Study Arms (2)

Guanidinoacetic acid

EXPERIMENTAL

Supplementation with dietary guanidinoacetic acid

Dietary Supplement: Guanidinoacetic acid

Placebo

PLACEBO COMPARATOR

Supplementation with cellulose

Other: Placebo

Interventions

Guanidinoacetic acidDIETARY_SUPPLEMENT

Dietary supplement

Guanidinoacetic acid
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults who fulfilled the 1994 CDC criteria for CFS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health, Exercise and Sport Sciences

Belgrade, Serbia, 11000, Serbia

Location

Related Publications (3)

  • 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.

    PMID: 23329885BACKGROUND

  • 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.

    PMID: 23351309BACKGROUND

  • 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.

    PMID: 24535415BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigue

Interventions

glycocyamine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Sergej M Ostojic, MD, PhD

    Faculty of Sport and Physical Education, Novi Sad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Biomedical Sciences

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 11, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

SE(1)