Assessment of Fatty Acid/Carnitine Homeostasis in Patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612001209886

Enrollment

Registered

2012-11-15

Start date

2012-09-05

Completion date

2013-08-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Single fasting blood samples will be collected from each study participant for analysis of endogenous plasma L carnitine, acylcarnitine and free fatty acid concentrations. Results will be utilised for the determination of indices of fatty acid/carnitine homeostasis, calculated as the ratio of plasma free fatty acid – acylcarnitine. At the time of blood sample collection, each study participant will complete validated questionnaires for assessment of fatigue severity (Fatigue Severity Scale) and quality of life (Medical Outcomes Study Short-Form 36, SF 36). 13C oleic acid breath testing will be conducted in a subgroup of participants. After an overnight fast, participants will be administered a single 50 mg oral dose of 13C oleic acid. Expired air samples will be collected prior to dose administration (baseline) and then at hourly intervals until 8 hours post-dose for analysis of 13CO2 content. Baseline-corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of oxidation of oleic acid. Results of fatty acid/carnitine profiling and 13C oleic acid breath testing obtained from patients with CFS/ME will be statistically compared to those obtained from healthy controls using analysis of variance (ANOVA). Statistical examination of the relationship between the determined indices of fatty acid oxidation and fatigue severity/quality of life will be conducted using linear regression.

Interventions

Observational study of fatty acid/carnitine homeostasis in CFS/ME. Participants will provide a single fasting blood sample from which plasma free fatty acid and carnitine levels will be determined and the ratio of fatty acid/carnitine levels calculated. In a sub-group of participants, assessment will also be conducted using standard 13C-oleic acid breath testing and baseline corrected expired air 13CO2 concentration-time data will be kinetically modelled to determine the rate and extent of fatty

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Participant is >=18 years of age at the time of informed consent. 2. Participant is a male or non-pregnant, non-lactating female. 3. Participant is either: i. a patient diagnosed with CFS/ME by a physician according to the standard diagnostic criteria; or ii. a healthy subject with no clinically significant conditions. 4. Participant is aware of the study procedures and the risks involved and voluntarily agrees to participate by providing written informed consent.

Exclusion criteria

1. Participant has received treatment with L-carnitine or any carnitine derivatives within 2 months of study participation. 2. Participant has received treatment with fatty acid-containing products within 2 months of study participation. 3. Participant has received treatment with a pharmacologic agent known to alter fatty acid/carnitine homeostasis within 2 months of study participation. 4. Participant has a known blood-borne viral infection, including HIV, Hepatitis B or Hepatitis C. 5. Participant has a history or current evidence of any condition, therapy or laboratory abnormality that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate. 6. Participant has participated in a clinical trial within 2 months of study participation that, in the opinion of the investigator, might affect the results of the study or may not be in the best interest of the individual to participate.

Outcome results