ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000683932

Ethics application status

Approved

Date submitted

24/04/2020

Date registered

15/06/2020

Date last updated

28/07/2024

Date data sharing statement initially provided

15/06/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Testing efficacy of Breath Pearls for management of bad breath associated with a very low calorie diet (VLCD)

Scientific title

Can compliance with VLCD be improved using Breath Pearls to manage halitosis: a prospective double blinded randomised controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Halitosis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will begin in the second week of the VLCD, either soft-gel capsules of peppermint oil (Breath Pearls™) or placebo. Two capsules will be taken orally three times a day (after meals). The placebo and active treatments will be identical in packaging and delivery.
Bottle of Breath Pearls/placebo will be collected by the study nurse on the morning of surgery to assess compliance for counting of the remaining capsules

Intervention code [1]

Treatment: Other

Comparator / control treatment

The placebo treatment is composed of sunflower oil

Control group

Placebo

Outcomes

Primary outcome [1]

Change in halitosis rating as assessed by change in HALT questionnaire score

Timepoint [1]

2 weeks after commencement of Very low calorie diet

Secondary outcome [1]

Any change in gastro intestinal quality of life questionnaire score

Timepoint [1]

The gastro intestinal quality of life questionnaire will be administered at the commencement of VLCD (0) time point, the end of week 1 and the end of week 2

Secondary outcome [2]

Compliance with VLCD assessed by measuring urine ketones the morning of surgery

Timepoint [2]

2 weeks after the commencment of VLCD,

Secondary outcome [3]

Measuring weight change from the commencement of VLCD to weight following 2 weeks of VLCD. Weight will be measured using the same digital weighing scales

Timepoint [3]

2 weeks post commencement of VLCD

Eligibility

Key inclusion criteria

Patients will be considered for inclusion if they are planned for bariatric surgery and on a VLCD.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• will not accept the randomisation process;
• have medical issues which contraindicate the application of either arm of the study such as acute myocardial infarction within the past 6 months, dementia, bulimia, active psychosis, concurrent experimental drug use, current pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure;
• are unable to understand the risks, realistic benefits and compliance requirements of the interventions.

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)

The random assignment of eligible patients will be computer generated by the Monash University School of Public Health and Preventative Medicine (SPHPM) data centre which employs this type of system for all major trials.

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

A telephone based system will be established which will allow a check of patent eligibility and randomisation only proceed if the patient meets the criteria. Randomisation will be clustered into blocks of between 6 and 8 to ensure even distribution.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

. For the primary endpoint, a 95% CI for the difference in proportions between groups will be inspected and equivalence will be declared if the ends of the CI both fall within the equivalence margin (-5%, +5%). If necessary, a secondary set of analyses will be performed to adjust for baseline characteristics that are found to be imbalanced between groups where imbalance is pre-specified as a 0.25 standard deviation difference in means (quantitative measures) or an odds ratio of 1.5 (binary measures). Multivariate analysis will be performed using multiple logistic regression for binomial outcomes adjusting for baseline imbalances and potential covariates. Data analysis will be completed by an independent statistician who will be blinded to the allocation of groups. We will analyze by Intent to Treat, Last Observation Carried Forwards (ITT LOCF), Observed case and by Completer analysis, to give estimates of the effect size based on each of these scenarios.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/08/2020

Actual

5/11/2020

Date of last participant enrolment

Anticipated

31/01/2021

Actual

12/04/2021

Date of last data collection

Anticipated

14/02/2021

Actual

12/05/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3144 - Malvern

Recruitment postcode(s) [2]

3181 - Windsor

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Myerton Australia PTY LTD

Address [1]

Suite 309, 1 Princess Street, Kew Victoria 3101

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Professor Wendy Brown
Department of Surgery
The Alfred Centre
99 Commercial Rd
Melbourne 3004 Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ramsay Health Research Governance Committeee

Ethics committee address [1]

Level 3, 5 Talavera Road
Macquarie Park NSW 2113
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/07/2020

Approval date [1]

28/08/2020

Ethics approval number [1]

HREC Reference number 2020-006

Summary

Brief summary

Patients who are planned to undergo bariatric surgery will typically undertake a Very Low Calorie Diet (VLCD) for two weeks prior to surgery to reduce the size of the liver and improve intraoperative laparoscopic access.  VLCD are effective as they create a state of Ketosis.  Ketosis leads to an unpleasant taste in the mouth and patients often struggle with this symptom whilst they are on the diet and can be one reason that they are not compliant with the treatment.  We have chosen this group to study rather than our gastroparesis and post-surgical patients as there are currently no other effective treatments that can be offered.  
We propose a double blinded randomised controlled trial to test the effectiveness of enterically delivered peppermint oil (Breath Pearls™) to improve the perception of breath quality for patients who are on a VLCD.  If this trial confirms that patients have the perception of improved breath quality, we will plan to further investigate the mechanism by which this occurs and also extend the study to other cohorts that may benefit from this treatment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Paul Burton

Address

Department of Surgery
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne 3004 Victoria

Country

Australia

Phone

+61 3 99030190

Fax

+61 3 99030717

paul.burton@monash.edu

Contact person for public queries

Name

Paul Burton

Address

Department of Surgery
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne 3004 Victoria

Country

Australia

Phone

+61 3 99030190

Fax

+61 3 99030717

paul.burton@monash.edu

Contact person for scientific queries

Name

Paul Burton

Address

Department of Surgery
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne 3004 Victoria

Country

Australia

Phone

+61 3 99030190

Fax

+61 3 99030717

paul.burton@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Deidentified data including weight , Questionnaire scores, and level of compliance using urine ketosis measurements

When will data be available (start and end dates)?

Staring immediately following publication with no end date

Available to whom?

Anyone who wishes to access it

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Data can be obtained by emailing the principal investigator, paul.burton@monash.edu

What supporting documents are/will be available?

Doc. No.	Type	Email
7766	Study protocol	Cheryl.laurie@monash.edu
7767	Statistical analysis plan	Cheryl.laurie@monash.edu
7768	Informed consent form	Cheryl.laurie@monash.edu
7769	Clinical study report	Cheryl.laurie@monash.edu
7770	Ethical approval	Cheryl.laurie@monash.edu

Results publications and other study-related documents

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No additional documents have been identified.

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