Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001285943
Ethics application status
Approved
Date submitted
2/10/2020
Date registered
27/11/2020
Date last updated
2/03/2022
Date data sharing statement initially provided
27/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Yeast Beta Glucan (Saccharomyces cerevisiae) compared to a placebo on cold and flu symptoms in an Adult Population – A double blind, randomised controlled trial.
Scientific title
Effect of Yeast Beta Glucan (Saccharomyces cerevisiae) compared to a placebo on cold and flu symptoms in an Adult Population – A double blind, randomised controlled trial.
Secondary ID [1] 302437 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BET-COL20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Cold 319253 0
Influenza viral infection 319254 0
Condition category
Condition code
Alternative and Complementary Medicine 317222 317222 0 0
Herbal remedies
Infection 317223 317223 0 0
Other infectious diseases
Respiratory 317517 317517 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double blind, randomised, clinical study with a 3-month participation and 2 groups (1 active ingredient group and 1 inactive placebo group). Saccharomyces cerevisiae is approved as an ingredient for use in Listed medicines on the ARTG (ingredient ID 79258).

Once enrolled in the study, participants will be randomly allocated to either a placebo group or an active intervention group. Following enrolment, participants will receive the trial product in the mail. Upon receiving the trial product, participants will register their start of trial product using a provided link to a secure, personalised login and then be asked to start consuming the allocated study product according to the dose prescribed (1 x 200 mg oral capsule daily). Following the start of the trial product, participants will be contacted electronically (text message and email) fortnightly to confirm they are still enrolled, still taking product as prescribed, if they have experienced any cold or flu symptoms (unless an event has been logged) or experienced any adverse events. During the 3-month study period, participants will be asked to complete a SF-8 questionnaire every 4-weeks.

Additionally, if a participant experiences the onset of cold or flu symptoms (e.g. cough, sneezing, stuffy or runny nose, fever, scratchy or sore throat and nasal breathing), participants will then be required to record their daily symptoms (including the severity) online using the WURSS-24 questionnaire for the duration of the event. If a participant’s symptoms continue for more that 2-weeks, they will be asked to seek medical advice (GP). If the GP thinks it is still just a cold or flu, at the discretion of the GP, the participant may continue to take the trial product if medication is not required. Once the participant has had a 2-week symptom free period, they may still log subsequent events within the trial period. Once symptoms of an event have subsided, participants are asked to continue to take the trial product for the remaining duration of the study period (up to 3-months total) and record any subsequent cold or flu episodes provided they have been symptom free for at least 2-weeks.
At the end of the 3 months, participation in the study will be considered complete regardless of if a cold or flu event has been logged or not.

Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.
Intervention code [1] 318725 0
Treatment: Drugs
Comparator / control treatment
The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. The placebo will be administered as a single capsule taken as a daily dose (1 capsule in the morning with water).
Control group
Placebo

Outcomes
Primary outcome [1] 325290 0
Cold and Flu incidence via submission of symptomatic Wisconsin Upper Respiratory Symptom Survey (WURSS-24) (composite outcome)
Timepoint [1] 325290 0
Cumulative data will be assessed at the completion of the intervention (3 months post-randomisation)
Secondary outcome [1] 387414 0
Cold or flu duration via submission of symptomatic WURSS-24 (composite outcome)
Timepoint [1] 387414 0
Baseline, daily from day 2-14 of cold or flu episode.
Secondary outcome [2] 387415 0
Change in cold or flu severity via WURSS-24 (composite outcome)
Timepoint [2] 387415 0
Baseline, daily from day 2-14 of cold or flu episode.
Secondary outcome [3] 387427 0
Change in general health via SF-8 questionnaire
Timepoint [3] 387427 0
Baseline, Month 1, Month 2, Month 3 post randomisation
Secondary outcome [4] 387428 0
Product tolerance to be assessed via SF-8 questionnaires
Timepoint [4] 387428 0
Baseline, Month 1, Month 2 and Month 3 post randomisation
Secondary outcome [5] 387429 0
Days off work via WURSS-24 questionnaire
Timepoint [5] 387429 0
Baseline, daily from day 2-14 of cold or flu episode.
Secondary outcome [6] 387430 0
Rescue medication use via WURSS-24 questionnaire
Timepoint [6] 387430 0
Baseline, daily from day 2-14 of cold or flu episode
Secondary outcome [7] 388373 0
Incidence of adverse events (e.g gastrointestinal upset) reported spontaneously by the participant or noticed by an investigator throughout the intervention period (Adverse events noticed by an investigator will be identified in online form submissions via monitoring by investigators throughout the study and during any cold and flu episodes submitted by the participant).
Timepoint [7] 388373 0
Baseline, daily from day 2-14 of cold or flu episode as well as either spontaneously reported by the participant or noticed by an investigator.

Eligibility
Key inclusion criteria
• Male and females aged 18-65 years old
• Able to provide informed consent
• Agree not to take any beta-glucan supplement or any other supplements (e.g. Echinacea, Vitamin C, zinc) or medications (e.g. Tamiflu, Relenza) aimed at preventing URTIs for the duration of the trial (3 months).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions or chronic asthma)*
• Anyone regularly (> 3 times per week) consuming unprocessed food high in beta-glucan or with added beta-glucan (e.g. oats, barley and shiitake mushrooms)
• Acute sickness experienced in the past 2 months
• Serious mood disorders or neurological disorders such as MS
• Active smokers and/or nicotine or drug abuse
• Chronic alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in active or placebo formula
• Pregnant or lactating woman
• People medically prescribed medications that would affect the immune and/or the inflammatory response.
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other related clinical study during the past 1 month
• People with cognitive damage
• People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year

*An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/11/2020
Date of last participant enrolment
Anticipated
Actual
28/05/2021
Date of last data collection
Anticipated
Actual
18/08/2021
Sample size
Target
250
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306861 0
Commercial sector/Industry
Name [1] 306861 0
Angel Yeast Co., Ltd.
Country [1] 306861 0
China
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd.
Address
3B/76 Doggett street, Newstead QLD, 4006
Country
Australia
Secondary sponsor category [1] 307419 0
Commercial sector/Industry
Name [1] 307419 0
Angel Yeast Co., Ltd.
Address [1] 307419 0
168, Chengdong Avenue, Yichang, Hubei, 443003 P.R. China
Country [1] 307419 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307019 0
Bellberry Limited
Ethics committee address [1] 307019 0
Ethics committee country [1] 307019 0
Australia
Date submitted for ethics approval [1] 307019 0
02/07/2020
Approval date [1] 307019 0
28/09/2020
Ethics approval number [1] 307019 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105758 0
Dr David Briskey
Address 105758 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105758 0
Australia
Phone 105758 0
+61 421 784 077
Fax 105758 0
Email 105758 0
[email protected]
Contact person for public queries
Name 105759 0
Amanda Rao
Address 105759 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105759 0
Australia
Phone 105759 0
+61 414 488 559
Fax 105759 0
Email 105759 0
[email protected]
Contact person for scientific queries
Name 105760 0
Amanda Rao
Address 105760 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105760 0
Australia
Phone 105760 0
+61 414 488 559
Fax 105760 0
Email 105760 0
[email protected]

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?

No Supporting Document Provided



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.