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Trial registered on ANZCTR


Registration number
ACTRN12620000643976
Ethics application status
Approved
Date submitted
6/04/2020
Date registered
3/06/2020
Date last updated
3/06/2020
Date data sharing statement initially provided
3/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the effect of meal replacements (FastFX and Optifast) on weight loss prior to Intragastric Balloon Insertion
Scientific title
Effect of FastFX vs Optifast for Low Energy Meal Replacement on weight prior to Intragastric Balloon Insertion: A Randomised Doubled Blinded Trial.


Secondary ID [1] 300955 0
Nil
Universal Trial Number (UTN)
Trial acronym
OLYMPIAN Trial

Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 316975 0
Condition category
Condition code
Diet and Nutrition 315138 315138 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317276 0
Treatment: Other
Comparator / control treatment
The control arm instruction will be to consume the single serve packet (53 grams) of Vanilla Flavour Optifast (as per manufacturer instruction). When reconstituted with 250mls of water, this should contain 201kcal per serve.
Participants will receive the same instructions as the exposure group: to take this 3x per day (breakfast, lunch, dinner), and get 2 weeks worth.
Control group
Active

Outcomes
Primary outcome [1] 323407 0
Body weight will measured using a digital balance accurate to 0.02 kg (Amtech Seca 876 Digital Floor Scales) with subjects in underwear after voiding their bladder. The same scale will be used for each recording.
Timepoint [1] 323407 0
Patients will be weighed at initial dietician consultation, and the day they begin their Meal Replacements, 1 week prior to balloon insertion, then following their 2 weeks of MR, prior to balloon insertion
Secondary outcome [1] 381845 0
Patient preference/acceptability (measured on questionnaire scoring) - see below

A 36 point questionnaire was designed for this study, but adapted questions from previous validated studies.
Questionnaire items were adapted from validated dietary questionnaires on a 5-point Likert scale. Statements are scored from 1(Strongly Agree) to 5 (Strongly Disagree). Thus, lower scores represent greater satisfaction with the diet. The scores for the statements in each of the five factors and for the total score are averaged across the non-missing items.

Questions were sampled to suitably reflect baseline behavioural characteristics and then measure the intervention including taste, cravings, satiety and mood. These items were trialled with patients and clinicians to explore their representation of the subdomains and to compare their various perspectives. After the examination of content validity, 36 items were retained.
Timepoint [1] 381845 0
After 2 weeks of meal replacement has been consumed
Secondary outcome [2] 381846 0
Body weight measured using a digital balance accurate to 0.02 kg (Amtech Seca 876 Digital Floor Scales) with subjects in underwear after voiding their bladder.
Timepoint [2] 381846 0
3, 6, 9, 12 months following balloon insertion
Secondary outcome [3] 382282 0
Taste (assessed using study specific questionnaire using 5 point Likert scale)
Timepoint [3] 382282 0
After consumption of 2 weeks of meal replacement
Secondary outcome [4] 382283 0
Cravings - assessed using study specific questionnaire using 5 point Likert scale
Timepoint [4] 382283 0
After consumption of 2 weeks of meal replacement
Secondary outcome [5] 382284 0
Satiety - assessed using study specific questionnaire using 5 point Likert scale
Timepoint [5] 382284 0
After consumption of 2 weeks of meal replacement
Secondary outcome [6] 382285 0
Mood - assessed using study specific questionnaire using 5 point Likert scale
Timepoint [6] 382285 0
After consumption of 2 weeks of meal replacement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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 randomisation schedule will be pre-determined prior to participant recruitment, such that the investigator involved in baseline participant assessment will have no involvement in treatment allocation. Envelopes containing randomisation group will be prepared by administration assistants, not otherwise involved in the study, according to the randomisation schedule produced by the statistician. Every envelope will be marked with a participant ID; the participant ID will be associated with the individual’s NHI and name in a dedicated spreadsheet when an envelope is handed out to an individual.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to the two treatment groups at a 1:1 ratio using randomly permutated block sizes of 4 generated by SAS version 9.4 (SAS Institute Inc, North Carolina, USA), and stratified according to baseline BMI (27.0 to 34.9 kg/m2; and 35.0 to 45.0 kg/m2).
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
Intervention assignment
Parallel
Other design features
Study participants and investigators involved in clinical data collection will be blinded from treatment randomisation until the end of the study period. Unblinding by research assistants will be allowed only in cases of potential allergic reaction to the ingredients. All other study personnel and subjects will be kept blinded to the treatment assignments.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc, North Carolina, USA). The primary analysis will be conducted using an intention to treat (ITT) approach with baseline observation carried forward. The primary non-inferiority outcome (relative weight loss) will be analysed using the non-inferiority margin-adjusted one-tailed independent samples t-test. A sensitivity analysis for the treatment effect on relative weight loss will also be performed within a multiple linear regression model framework incorporating treatment group and baseline weight. The two-sided 90% confidence intervals for the mean difference between the two treatment groups will also be calculated to facilitate qualitative comparison with the pre-specified non-inferiority margin. Secondary superiority outcomes will be assessed using the two-tailed independent t-test for continuous measurement with normal distributions confirmed by Shapiro-Wilk testing (p>0.05). Non-normally distributed continuous and ordinal data will be analysed using the two-tailed Mann-Whitney U-test, and categorical data using the two-tailed Fisher’s exact test. Data will be presented as mean±SD, median (IQR), number of participants (% of participants), unless otherwise stated, and p<0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22473 0
New Zealand
State/province [1] 22473 0
Auckland

Funding & Sponsors
Funding source category [1] 305399 0
Commercial sector/Industry
Name [1] 305399 0
Macmurray Gastroenterology and Endoscopy Center
Address [1] 305399 0
3 Macmurray Rd, Remuera, Auckland 1050
Country [1] 305399 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Macmurray Gastroenterology and Endoscopy Center
Address
Macmurray Gastroenterology and Endoscopy Center
3 Macmurray Road,
Remuera, Auckland 1050
New Zealand
Country
New Zealand
Secondary sponsor category [1] 305784 0
Commercial sector/Industry
Name [1] 305784 0
HealthFX
Address [1] 305784 0
Macmurray Gastroenterology and Endoscopy Center
3 Macmurray Road,
Remuera, Auckland 1050
New Zealand
Country [1] 305784 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305723 0
Health and Disability Ethics Committees
Ethics committee address [1] 305723 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305723 0
New Zealand
Date submitted for ethics approval [1] 305723 0
06/04/2020
Approval date [1] 305723 0
28/04/2020
Ethics approval number [1] 305723 0
20/CEN/83

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101358 0
Dr Alasdair Patrick
Address 101358 0
Macmurray Gastroenterology and Endoscopy Center.
3 Macmurray Rd, Remuera,
Auckland 1050
Country 101358 0
New Zealand
Phone 101358 0
+6421681323
Fax 101358 0
Email 101358 0
alasdair.patrick@middlemore.co.nz
Contact person for public queries
Name 101359 0
Dr Alasdair Patrick
Address 101359 0
Macmurray Gastroenterology and Endoscopy Center.
3 Macmurray Rd, Remuera,
Auckland 1050
Country 101359 0
New Zealand
Phone 101359 0
+6421681323
Fax 101359 0
Email 101359 0
alasdair.patrick@middlemore.co.nz
Contact person for scientific queries
Name 101360 0
Dr Alasdair Patrick
Address 101360 0
Macmurray Gastroenterology and Endoscopy Center.
3 Macmurray Rd, Remuera,
Auckland 1050
Country 101360 0
New Zealand
Phone 101360 0
+6421681323
Fax 101360 0
Email 101360 0
alasdair.patrick@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be anonymised.
What supporting documents are/will be available?
Study protocol
Informed consent form
Other
'Other' documents specified
Review of study protocol, feasibility and acceptability by Dr Anurag Sekra, a specialist in this field.
How or where can supporting documents be obtained?
Type [1] 7539 0
Study protocol
Citation [1] 7539 0
Link [1] 7539 0
Email [1] 7539 0
Other [1] 7539 0
Type [2] 7540 0
Statistical analysis plan
Citation [2] 7540 0
Statistical analysis plan is within the protocol (see attachment 1)
Link [2] 7540 0
Email [2] 7540 0
Other [2] 7540 0
Attachment [2] 7540 0
Type [3] 7541 0
Informed consent form
Citation [3] 7541 0
Link [3] 7541 0
Email [3] 7541 0
Other [3] 7541 0
Type [4] 7542 0
Other
Citation [4] 7542 0
Link [4] 7542 0
Email [4] 7542 0
Other [4] 7542 0
This was a review completed by Dr Anurag Sekra, Gastroenterology Senior Medical Officer (designed for the HDEC review).
Summary results
No Results