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Examining Diet, Immune Function, and Fatigue in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis patients

Investigating the Interactions Between Diet, Immune Function, and Fatigue in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001369415
Enrollment
100
Registered
2025-12-08
Start date
2026-07-01
Completion date
2026-12-01
Last updated
2026-06-15

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

Conditions

None listed

Brief summary

CFS/ME is a debilitating disease characterised by severe, unexplained fatigue lasting for more than 6 months with additional symptoms affecting the entire body. CFS/ME has no known causes, no definitive diagnostic biomarkers, and very limited treatment options. Dysfunction of the immune system is common in CFS/ME and while many people with CFS/ME find that dietary modification can improve symptoms, the research behind this is lacking. This study therefore aims to determine whether diet and immune function differ between CFS/ME patients compared to healthy controls, and whether they possibly interact to affect symptoms of CFS/ME.

Interventions

Participants will attend 1 study visit at Swinburne University of Technology, Hawthorn campus. At this visit, they will be asked to provide a blood sample (taken by a Division 1 registered research nurse or suitably qualified venepuncture technician) and complete a number of questionnaires regarding their fatigue, diet, mood, and quality of life. The questionnaires being utilised in this study are the Chalder Fatigue Scale (5 minutes to complete), MedWalk Mediterranean Diet Adherence Screener (M

Participants will attend 1 study visit at Swinburne University of Technology, Hawthorn campus. At this visit, they will be asked to provide a blood sample (taken by a Division 1 registered research nurse or suitably qualified venepuncture technician) and complete a number of questionnaires regarding their fatigue, diet, mood, and quality of life. The questionnaires being utilised in this study are the Chalder Fatigue Scale (5 minutes to complete), MedWalk Mediterranean Diet Adherence Screener (MW-MEDAS) (5 minutes to complete), Depression Anxiety Stress Scale (DASS-21) (5 minutes to complete), and the Short Form 36 (SF-36) (10 minutes to complete). At the completion of this visit, each participant will be provided with an ActiGraph accelerometer (wGT3X-BT; ActiGraph, FL, USA) and instructions to wear for 8 days, removing it only when sleeping, swimming, and bathing, as well as access to an online or hardcopy version of a diet diary (FoodWorks Version 7.1.0, Xyris Pty Ltd) with instruction to track all food and beverage intake over a 4 day period including at least 1 weekend day.

Sponsors

Swinburne University of Technology
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

- Aged 18-40 - CFS/ME patients: Currently meet the Fukuda CFS/ME case definition - Controls: Not currently meeting the Fukuda CFS/ME case definition and no history of CFS/ME diagnosis - Fluent in written and spoken English - Willing to provide blood samples - Willing to complete all scheduled tasks

Exclusion criteria

- Women: Peri-/Post-menopause - Diagnosis of chronic medical or psychiatric condition (e.g. depression, autoimmune disease, mast cell activation syndrome, morbid obesity/BMI >40) - Taking immunomodulating medications or supplements regularly (e.g. statins, anti-depressants, non-steroidal anti-inflammatory agents) - Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026