None listed
Conditions
Brief summary
We hypothesise that Fast FX, as a low energy meal replacement will be non-inferior for weight loss after 2 weeks of consumption prior to intragastric balloon insertion, as compared to the current standard of Optifast. We will also measure patient preference/acceptability and adherence as measured by our questionnaire, specifically taste, satiety, cravings and mood.
Interventions
The intervention is FastFX meal replacement, taken for 2 weeks, instead of the current standard of Optifast.
Following randomisation, patients will receive from the dietician 2 week’s worth of meal replacement in single-serve plain snap lock bags only labelled with instruction and randomisation code. Both products are powders.
The intervention arm will be near identical in makeup to the control - a white powder that patients mix a single serve (60 grams) of FastFX, equivalent to 201kcal whe
The intervention is FastFX meal replacement, taken for 2 weeks, instead of the current standard of Optifast. Following randomisation, patients will receive from the dietician 2 week’s worth of meal replacement in single-serve plain snap lock bags only labelled with instruction and randomisation code. Both products are powders. The intervention arm will be near identical in makeup to the control - a white powder that patients mix a single serve (60 grams) of FastFX, equivalent to 201kcal when reconstituted with 400mls of water. Patients are instructed to take this 3 times per day (breakfast, lunch, dinner). Additionally, both groups will be advised by dieticians to supplement this only with 2 cups of non-starch vegetables (https://www.optifast.com.au/optifast-vlcd-program/optifast-vlcd-program/allowed-vegetables-and-additional-food-allowances) and up to 2 litres of water. Patients adherence to taking the meal replacement will be via clinical questioning at time of clinical review. Following this intervention, the intragastric balloon insertion will be placed within 1 week.
Sponsors
The Macmurray Gastroenterology and Endoscopy Center
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
All patients presenting to the clinic and eligible for IGB insertion will be entitled to enrol in the trial. Standard patient selection for IGB insertion will apply: Adults, aged 18–65 years with obesity and a body mass index (BMI) of >27 and <45kgm2
Exclusion criteria
Patients will be excluded from this trial only if they do not consent to participation or have an allergy to the listed ingredients of the meal replacements.
Outcome results
None listed