Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000911695
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
26/08/2014
Date last updated
24/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The determination of the satiety effect of dietary fibre using trained panelists
Scientific title
The effect of training on the reliability of satiety evaluation and use of trained panelists to determine the satiety effect of dietary fibre
Secondary ID [1] 285176 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preventative obesity 292771 0
Condition category
Condition code
Diet and Nutrition 293064 293064 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
1. effect of a training intervention versus no-training on the test-retest precision and reliability of 2 hr post-prandial satiety evaluation after consumption of a standard breakfast.

Standard breakfast (total weight 228g) containing cereal flakes (15g each of Kellogg’s 'registered trademark' Branflakes 'registered trademark' , Cornflakes 'registered trademark' and Special K 'registered trademark' , sultanas (8g) and whole milk (175g) with an energy content of 1261 kJ

Panelists will be instructed to fast overnight for 10 hours and consume only water prior to consumption of the standard breakfast. Panelists then complete the labeled magnitude satiety scale. Panelists are tested on 4 occasions with a 3 to 7 day washout.

All breakfast bowls are checked to ensure the entire meal was consumed.

During the training intervention fasted panelists will consume the standard breakfast meal at time point 0 and complete the LMS. All LMS results will then be transcribed on a whiteboard and the results discussed. Through discussion consensus will be reached by the panelists on the meaning of the descriptor words and an agreed set of more detailed definitions of the descriptors will be generated by the panel through a process of voting. The training session will occur once during the study, seven days before the 4 test occasions and will be for 1 hour. It will be administered by a primary researcher using a pre-defined scripted protocol.
Arm 2
2. The trained panelist from arm 1 will complete arm 2. Panelists will fast for 10 hours. A standard breakfast meal with 5g of viscous fibre PGX (A) will be consumed in random order with the control consumed 5g of inulin (B).

Panelists will mark their fasting level of hunger/fullness on the labeled magnitude satiety scale (LMS) over a 2 hour period. Panelists will arrive for breakfast at 8am and must consume the meal in 12 minutes. Panelists will be tested on 8 occasions (the controls of inulin and wheat dextrin will be tested twice, PGX granules will be tested twice and PGX gels tested twice) with a 3 to 7 day washout. Blood sample taken at the 7 time points over 2 hours will be used to determine if a relationship with the satiety rating at the same points exists
Intervention code [1] 290030 0
Behaviour
Comparator / control treatment
Arm 1: training of satiety panel versus no training
Arm 2 inulin and wheat dextrin as controls
Control group
Active

Outcomes
Primary outcome [1] 292930 0
The training study will be conducted to determine the effect on the reliability of the satiety panel. Intra-class correlation (ICC) between test and retest will be used to determine the effect of training on the reliability of the panel. Satiety will be assessed using a 190mm labeled magnitude satiety scale (LMS). Postprandial glycaemia will be assessed using finger prick blood samples and a Glucose analyser.
Timepoint [1] 292930 0
Satiety will be assessed twice before the intervention and twice after the intervention. Hunger and fullnes will be assessed at time 0 then panelists consume breakast within 12 minutes, 15 minutes after commencement of eating panelist again mark the LMS, then every 15 minutes for 1 hour and every 30 minutes for the second hour a total of 2 hours.Time 1,2,3,4 have a 3 to 7 day washout between test. Postprandial glycaemia will be measure by finger print bloods at each time point over the 2 hours.
Primary outcome [2] 292931 0
Post Prandial satiety response by labelled magnitude satiety line scale (LMS).Hunger and fullness will be assessed following the protocol in outcome 1.
Timepoint [2] 292931 0
Arm 2 -time 0 (after 10hr fast), 15, 30, 45, 60, 90, 120 minutes
Secondary outcome [1] 309975 0
nil
Timepoint [1] 309975 0
nil

Eligibility
Key inclusion criteria
Healthy adults aged 19-53 years. BMI 18.1 - 29.5 kg/m^2
Minimum age
19 Years
Maximum age
53 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria were: smokers; pregnant women; individuals taking medication known to affect satiety; individuals with food allergies; excessive alcohol consumers and; any history of diabetes, gastrointestinal or cardiovascular diseases. Not previously participated in a satiety panel for Arm 1.

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 staff and student population of Curtin University (Perth, Australia). All the participants will be recruited through flyers, posters, information sessions. Flyers will be distributed at public places around Curtin University. Completed screening questionnaires will be assessed for compliance to selection criteria prior to acceptance of participants into the study. Acceptance letters will be sent to eligible candidates that will contain information on the times and venue for the test days and all the tasks required to be performed on the test days.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The person determining if the subject will be eligible for inclusion in the study will be unaware to which group the subject would be allocated. Allocation will be concealed by central randomised computer and each subject will be allocated a three digit code at this point. Randomisation will be generated using a computer generated three digit code. Each panelist will be allocated a 3 digit code using computerised sequence generation.
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
Parallel for training Arm 1
Cross over for Arm 2
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be performed using Stata statistical software (SE 12.1, StataCorp, College Station, TX, USA) and values of p < 0.05 will be considered as significant.
Each panelist’s satiety score (n=23) at each test time point (baseline, 15, 30, 45, 60, 90, 120 minutes), will be used to generate postprandial satiety curve for each test occasion and the area under the postprandial satiety curve (AUC) will be calculated using the trapezoidal rule. Test-retest reliability will be determined using intraclass correlation (ICC). Differences in postprandial satiety response and postprandial glucose response after the consumption of fibre will be determined from AUC.
14 panelists are needed for a power of 0.9 (Flint et al 2000).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
30/05/2014
Actual
30/05/2014
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8575 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 289786 0
Commercial sector/Industry
Name [1] 289786 0
Factors Group Pty Ltd
Country [1] 289786 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley, 6102, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 288476 0
Commercial sector/Industry
Name [1] 288476 0
Factors Group Pty Ltd
Address [1] 288476 0
Unit 1, 11 Lang Parade, Milton,4064, Queensland.
Country [1] 288476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291523 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291523 0
Ethics committee country [1] 291523 0
Australia
Date submitted for ethics approval [1] 291523 0
Approval date [1] 291523 0
16/01/2014
Ethics approval number [1] 291523 0
HR03/2014
Ethics committee name [2] 291524 0
Curtin University Human Ethic Committee
Ethics committee address [2] 291524 0
Ethics committee country [2] 291524 0
Australia
Date submitted for ethics approval [2] 291524 0
Approval date [2] 291524 0
14/08/2013
Ethics approval number [2] 291524 0
SPH42/2013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50726 0
A/Prof Vicky Solah
Address 50726 0
Nutrition, Dietetics and Food Science, School of Public Health, Curtin University, GPO Box U1987, Perth, 6845, Western Australia
Country 50726 0
Australia
Phone 50726 0
61 8 92662771
Fax 50726 0
61 8 92662958
Email 50726 0
[email protected]
Contact person for public queries
Name 50727 0
Vicky Solah
Address 50727 0
Nutrition, Dietetics and Food Science, School of Public Health, Curtin University, GPO Box U1987, Perth, 6845, Western Australia
Country 50727 0
Australia
Phone 50727 0
61 8 92662771
Fax 50727 0
61 8 92662958
Email 50727 0
[email protected]
Contact person for scientific queries
Name 50728 0
Vicky Solah
Address 50728 0
Nutrition, Dietetics and Food Science, School of Public Health, Curtin University, GPO Box U1987, Perth, 6845, Western Australia
Country 50728 0
Australia
Phone 50728 0
61 8 92662771
Fax 50728 0
61 8 92662771
Email 50728 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
EmbaseConsumption of the soluble dietary fibre complex polyglycopleX reduces glycaemia and increases satiety of a standard meal postprandially.2016https://dx.doi.org/10.3390/nu8050268
N.B. These documents automatically identified may not have been verified by the study sponsor.