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EFFECT Trial: Evaluating Fermentable Fibre as a Long COVID Therapy

Investigating the immunomodulatory and clinical effects of fermentable fiber dietary intervention to reduce symptoms of post-acute sequelae of SARS-CoV-2 infection in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000356561
Enrollment
28
Registered
2024-03-28
Start date
2025-05-30
Completion date
Unknown
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

Post-acute sequelae of SARS-CoV-2 infection (PASC) or Long COVID is a chronic condition that causes an array of symptoms, affecting multiple body systems. Although Long COVID may affect up to 10% of those who are infection with SARS-CoV-2, there is still poor understanding of disease pathology. Cohort studies of Long COVID patients have observed dysbiosis of the gut microbiota in these patients when compared to healthy subjects. Long COVID patients have reduced abundance of short-chain fatty acid (SCFA) producing bacteria, particularly butyrate producing species that are important for maintenance of gut homeostasis. However, it remains unclear if the reduction in butyrate-producing species may contribute to underlying disease in Long COVID. Increasing butyrate and SCFA concentrations has been observed to have anti-inflammatory effects in other immune-mediated models of disease, and have been proposed as a potential therapeutic to treat Long COVID. It remains unknown if increasing SCFA delivery has any therapeutic benefit in Long COVID. Our study team has extensive experience with supplementing fermentable fiber into the diet to increase SCFA concentrations in people. Therefore, we aim to investigate if fermentable fiber supplementation has therapeutic benefit in Long COVID patients. This will be via a dietary intervention study, to assess if fermentable fiber supplementation improves symptoms of Long COVID.

Interventions

This study is a double-blinded dietary intervention study with a parallel design. During the 3-week dietary intervention, participants will consume their habitual diet, supplemented with 20 g fermentable fiber/day (10 g inulin, 10 g resistant starch- HiMaize) added to 2 intervention food items. The intervention food items will be prepared by our research chef and dietitian, at a metabolic kitchen at the Department of Nutrition and Dietetics at Monash University. The intervention items are fro

This study is a double-blinded dietary intervention study with a parallel design. During the 3-week dietary intervention, participants will consume their habitual diet, supplemented with 20 g fermentable fiber/day (10 g inulin, 10 g resistant starch- HiMaize) added to 2 intervention food items. The intervention food items will be prepared by our research chef and dietitian, at a metabolic kitchen at the Department of Nutrition and Dietetics at Monash University. The intervention items are frozen and then supplied to the participants to reheat and consume at home. These will be a range of baked goods such as muffins, pancakes and muesli bars. This approach has been used previously by our study team. Participants will be instructed to maintain their normal dietary pattern during the intervention period. The participants will be blinded to the nature of the intervention. Participants will record their consumption of study items a study booklet. Furthermore, participants will be asked to complete 6 daily food diaries during the intervention period to monitor background dietary intake.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults (18 years and over) • Diagnosis of Long COVID, defined as symptoms persisting for more than 3 months after being infected with SARS-CoV-2 • Experiencing symptoms of Brain fog and fatigue

Exclusion criteria

• Currently taking immunosuppressive medications • Have taken antibiotics in the past 2 months • Existing history of functional gut symptoms indicative of poor tolerance to fermentable fibres • Currently adhere to a vegan or vegetarian diet • Pregnant or planning pregnancy • Unable to speak or read English

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026