Trial Review

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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] 311673 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID 333135 0
Condition category
Condition code
Infection 329830 329830 0 0
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] 328138 0
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] 337598 0
Comparison of Long COVID symptoms of fatigue from baseline between placebo and fermentable fibre intervention.
Timepoint [1] 337598 0
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] 432468 0
Assessment of tolerability to fermentable fibre
Timepoint [1] 432468 0
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?
No
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
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316000 0
University
Name [1] 316000 0
Monash University
Country [1] 316000 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318152 0
None
Name [1] 318152 0
Address [1] 318152 0
Country [1] 318152 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314826 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314826 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314826 0
Australia
Date submitted for ethics approval [1] 314826 0
07/03/2024
Approval date [1] 314826 0
Ethics approval number [1] 314826 0

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132846 0
Dr Jane Varney
Address 132846 0
Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004
Country 132846 0
Australia
Phone 132846 0
+61412944848
Fax 132846 0
Email 132846 0
jane.varney@monash.edu
Contact person for public queries
Name 132847 0
Jane Varney
Address 132847 0
Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004
Country 132847 0
Australia
Phone 132847 0
+61412944848
Fax 132847 0
Email 132847 0
jane.varney@monash.edu
Contact person for scientific queries
Name 132848 0
Jane Varney
Address 132848 0
Dept of Gastroenterology, Monash University, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne 3004
Country 132848 0
Australia
Phone 132848 0
+61412944848
Fax 132848 0
Email 132848 0
jane.varney@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21806Study protocol    387447-(Uploaded-05-03-2024-21-23-02)-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.