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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000683932

Enrollment

Registered

2020-06-15

Start date

2020-11-05

Completion date

2021-04-12

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

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.

Outcome results