Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000701628
Ethics application status
Approved
Date submitted
24/06/2014
Date registered
3/07/2014
Date last updated
24/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of fibre supplementation on the frequency of eating occasions
Scientific title
The effect of fibre supplementation on the frequency of eating occasions in overweight individuals.
Secondary ID [1] 284865 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventative Obesity 292267 0
Condition category
Condition code
Diet and Nutrition 292623 292623 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.
a) Viscous fibre supplement, PGX, 5g two or 3 times daily administered over a 12-week period.
b) mode is granules mixed with food and taken with water

2.unused sachets will be returned and a daily mobile phone food record will be taken and images are sent to the Curtin University server Viscous fibre supplement.
Intervention code [1] 289671 0
Behaviour
Intervention code [2] 289689 0
Treatment: Other
Comparator / control treatment
Treatment which is fibre versus control which is a rice flour placebo in identical sealed silver coloured sachets
Control group
Placebo

Outcomes
Primary outcome [1] 292461 0
Frequency of eating occasions. This will be determined using the image metadata from the 4-day Mobile Phone Food Record (mdFR).
Timepoint [1] 292461 0
week 1, week 6 and week 12 after start of study
Secondary outcome [1] 309020 0
Anthropometric variables –height, weight, hip, waist girth will be measured according to a standard protocol (Stewart et al. 2011).
Height using a stadiometer
weight using calibrated digital scales
waist circumference using a metal tape
Timepoint [1] 309020 0
time 0 and at 12 weeks
Secondary outcome [2] 309105 0
blood pressure with an automated omron blood pressure monitor
Timepoint [2] 309105 0
time 0 and at 12 weeks
Secondary outcome [3] 309106 0
serum cholesterol - bloods sent for analysis
Timepoint [3] 309106 0
time 0 and 12 weeks

Eligibility
Key inclusion criteria
Overweight as defined by a body weight index (BMI) of 25 – 29 kg/m2 and not under current medical supervision
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if (a) pregnant; (b) unable to complete the 12 week study; (c) undertake extreme forms of exercise or dieting; or (d) unable to attend the study centre on four occasions (two at baseline for satiety training and dietary training and for fasting blood, weight height and waist circumference and final visit at 12 weeks; e) are smokers; f) have an allergy to any food ingredients used in the study; g) current use of lipid-lowering or antihypertensive drugs, insulin injection use; h) renal, liver or respiratory failure; i) previous gastric or weight-loss surgery; j) any malabsorptive conditions and current or recent dietary fibre supplementation. Subjects must be weight stable – i.e. weight fluctuations not greater than +/- 5 kg in last 12 months. Subject will not be restrained eater on entry to the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the general population by way of flyers, posters, information sessions and Curtin University radio and email communication systems. Flyers will be distributed around the university as well as in public places such as shopping centres. Access to the email adresses of both staff and students from the Faculty of Health Sciences will be requested in order to directly invite them to participate in the study.Individuals that express interest will complete a questionnaire to determine whether they meet the selection criteria. If they do, further details of the study will be explained to them and they can decide whether they are willing to participate. Those that agree will be required to attend an information session at Curtin University during which informed consent will be obtained and the study objectives and participant requirements will be further explained. Allocation is concealed in sealed silver foil sachets labelled with a six digit code. Allocation file is held by a single administrator /code keeper at central administration. Participants will be randomised to either the test treatment, PGX (n = 60) or the rice flour placebo (n = 60).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation was generated using computer generated three digit codes. So the participants are coded with 3 digits.
Each foil sachet (single dose) is stamped with a 6 digit code which incorporated the participant code and production code.
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean within-group changes in frequency of eating occasions will be assessed using repeated-measures analysis, while time-by-treatment analysis of covariance will be used to determine between-group differences over time. Within-group changes, paired sample t test will be used as there are only two time points. Weight, height, waist circumference:Treatment effect can be examined by analysis of time-by-treatment variables.Using general linear models, regression analysis will be used to determine the extent to which body weight changed between baseline and the final week of the study. For occasion of eating
The maximum times of eating occasions is set at 10 with a expected drop of 2 occasions and allowing for a drop of 5 or 3 meals in a day, plus allowing for an increase (though not expected).So mu0 10, mu1 8 and sigma 5 to give a power of 0.8 requires 50 participants.
For weight loss
The lowest weight expected is 80Kg with a 4 kg loss and possible 12 kg loss -SO mu0 80kg, mu1 76kg and sigma 12 requires 71 participants . The upper weight limit of 95kg and maximum 5-18 kg loss so mu0 95kg, mu1 90 and sigma of 18 , 108 participants are required. The 120 subjects are to allow for drop outs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2014
Actual
9/09/2014
Date of last participant enrolment
Anticipated
29/02/2016
Actual
17/03/2016
Date of last data collection
Anticipated
Actual
27/04/2016
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8339 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 289480 0
Commercial sector/Industry
Name [1] 289480 0
FACTORS GROUP PTY LTD (ACN 097 127 332)
Country [1] 289480 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St Bentley 6102 Western Australia
GPO Box U1987 6845 Perth Western Australia
Country
Australia
Secondary sponsor category [1] 288165 0
Commercial sector/Industry
Name [1] 288165 0
FACTORS GROUP PTY LTD (ACN 097 127 332)
Address [1] 288165 0
Principal office: Unit 1, 11 Lang Parade, Milton, Queensland 4064
Country [1] 288165 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291237 0
Curtin University Ethics Committee
Ethics committee address [1] 291237 0
Ethics committee country [1] 291237 0
Australia
Date submitted for ethics approval [1] 291237 0
04/07/2014
Approval date [1] 291237 0
05/02/2015
Ethics approval number [1] 291237 0
HR170/2014/AR1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 103 103 0 0
/AnzctrAttachments/366598-Occasions of Eating Research Proposal June 23 2014.pdf

Contacts
Principal investigator
Name 49450 0
A/Prof Vicky Solah
Address 49450 0
Nutrition, Dietetics and Food Science
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country 49450 0
Australia
Phone 49450 0
61 8 92662771
Fax 49450 0
61 8 92662958
Email 49450 0
[email protected]
Contact person for public queries
Name 49451 0
Vicky Solah
Address 49451 0
Nutrition, Dietetics and Food Science
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country 49451 0
Australia
Phone 49451 0
61 8 92662771
Fax 49451 0
61 8 92662958
Email 49451 0
[email protected]
Contact person for scientific queries
Name 49452 0
Vicky Solah
Address 49452 0
Nutrition, Dietetics and Food Science
School of Public Health
Curtin University
GPO Box U1987
Perth 6845
Western Australia
Country 49452 0
Australia
Phone 49452 0
61 8 92662771
Fax 49452 0
61 8 92662958
Email 49452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of fibre supplementation on body weight and composition, frequency of eating and dietary choice in overweight individuals.2017https://dx.doi.org/10.3390/nu9020149
EmbaseEffect of polyGlycopleX (PGX) consumption on blood lipid profiles in healthy, low CVD risk overweight adults.2019https://dx.doi.org/10.3390/nu11040717
N.B. These documents automatically identified may not have been verified by the study sponsor.