ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12624000356561p

Ethics application status

Submitted, not yet approved

Date submitted

5/03/2024

Date registered

28/03/2024

Date last updated

28/03/2024

Date data sharing statement initially provided

28/03/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

EFFECT Trial: Evaluating Fermentable Fibre as a Long COVID Therapy

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Long COVID

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The placebo arm will mirror the intervention arm, except that intervention food items will be supplemented with low-fiber rice flour.

Control group

Placebo

Outcomes

Primary outcome [1]

Comparison of Long COVID symptoms of fatigue from baseline between placebo and fermentable fibre intervention.

Assessment method [1]

Long COVID Symptom Burden Questionnaire. This will be a modified version of the Long COVID Symptom burden questionnaire (University of Birmingham), only containing sections on Fatigue, Memory, Thinking, communication and Impact on Daily Life.

Timepoint [1]

Symptoms will be assessed at baseline (pre-intervention) and at the end of the intervention (end of week 3). The change in symptoms at the end of the intervention compared to baseline will be compared between each arm of the study.

Secondary outcome [1]

Assessment of tolerability to fermentable fibre

Assessment method [1]

Gastrointestinal symptom questionnaire

Timepoint [1]

Gastrointestinal symptoms will be assessed at baseline (pre-intervention) and at the end of the intervention period (Week 3).

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation using an online randomisation tool (randomisation.com) participants will be randomised (1:1) to either the Placebo diet or Fermentable fibre diet. A researcher independent to the research team will generate the randomisation sequence.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2024

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2024

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Jane Varney

Address

Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004

Country

Australia

Phone

+61412944848

jane.varney@monash.edu

Contact person for public queries

Name

Jane Varney

Address

Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004

Country

Australia

Phone

+61412944848

jane.varney@monash.edu

Contact person for scientific queries

Name

Jane Varney

Address

Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004

Country

Australia

Phone

+61412944848

jane.varney@monash.edu

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21806	Study protocol					Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically