Testing efficacy of Breath Pearls for management of bad breath associated with a very low calorie diet (VLCD)
Not Applicable
Completed
- Conditions
- HalitosisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12620000683932
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in halitosis rating as assessed by change in HALT questionnaire score[ 2 weeks after commencement of Very low calorie diet]
- Secondary Outcome Measures
Name Time Method Any change in gastro intestinal quality of life questionnaire score[ 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];Compliance with VLCD assessed by measuring urine ketones the morning of surgery[ 2 weeks after the commencment of VLCD, ];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[ 2 weeks post commencement of VLCD]