Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000428864
Ethics application status
Approved
Date submitted
27/03/2012
Date registered
17/04/2012
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing food products for feelings of fullness
Scientific title
In healthy individuals, will consumption of commercially available food products result in significantly different subjective ratings of satiety
Secondary ID [1] 280225 0
NIL
Universal Trial Number (UTN)
U1111-1129-5258
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Controlling feelings of satiety 286172 0
Condition category
Condition code
Diet and Nutrition 286367 286367 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 286413 286413 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume commerically available food products such as breakfast cereal and complete visual analogue scales rating feelings of hunger, fullness, desire to eat, thirst and levels of energy. Satiety will be assessed further through access to an ad libitum lunch

Products consumed will be breakfast cereals and ready to drink breakfast drinks and are: Nutrigrain, Special K, Weet-bix, Primo extremo choclate, Up & Go chocolate, Up & Go Vive Banana, muesli, Light & Tasty berry flavour. Products will be tested with 72 hours between each visit (max 2/week) for up to 4 weeks. Testing will take place over a morning period of up to 4 hours. Prior to leaving participants will be given an ad libitum lunch which will be measured covertly for energy intake. Each participant will test all of the 8 products in the trial.
Intervention code [1] 284556 0
Treatment: Other
Intervention code [2] 284557 0
Lifestyle
Intervention code [3] 284558 0
Behaviour
Comparator / control treatment
Each particpant will act their own control testing all eight products in the trial. No product will be a control, the trial is to discern what type of product has the greatest satiety effect.
Control group
Active

Outcomes
Primary outcome [1] 286823 0
Subjective ratings of satiey using visual analogue scales
Timepoint [1] 286823 0
time intervals of 15 minutes for the first hour, then 30 minute intervals up to a time point of 210 minutes
Primary outcome [2] 286859 0
The State/trait anxiety questionnaire published by Mindgarden.
Timepoint [2] 286859 0
At baseline and at the end of the testing period.
Primary outcome [3] 286860 0
The Dutch eating questionnaire
Timepoint [3] 286860 0
At baseline
Secondary outcome [1] 296735 0
Satiety assessed using amount of food consumed at ad libitum lunch
Timepoint [1] 296735 0
3.5 hours following the initial test product
Secondary outcome [2] 296814 0
Development of new food concepts for future food development
Timepoint [2] 296814 0
Following assessment of the trial and the different factors involved in satiety

Eligibility
Key inclusion criteria
Subjects will be healthy male individuals (age 18-55) with healthy weight (BMI 19-25 kg/M2 ) and normal glucose tolerance (fasting glucose < 5.6mmol/L). No evidence of chronic disease and no medications
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will include: smoking, medication, food allergy/intolerance, dieting, physical or mental illness.

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)
Subjects will be enrolled by investigators folllowing a face to face interview. Particpants will be randomised to products using simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2012
Actual
17/04/2013
Date of last participant enrolment
Anticipated
18/06/2013
Actual
11/06/2013
Date of last data collection
Anticipated
Actual
11/12/2013
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 4224 0
New Zealand
State/province [1] 4224 0
Christchurch

Funding & Sponsors
Funding source category [1] 284980 0
Government body
Name [1] 284980 0
Foundation for Research Science & Technology (now Ministry of Science & Innovation)
Country [1] 284980 0
New Zealand
Primary sponsor type
Government body
Name
Plant & Food Research (Crown Research Institute)
Address
Gerald Street
Lincoln
PO Box 4704
Christchurch 8074
Country
New Zealand
Secondary sponsor category [1] 283844 0
None
Name [1] 283844 0
Address [1] 283844 0
Country [1] 283844 0
Other collaborator category [1] 260659 0
Commercial sector/Industry
Name [1] 260659 0
Sanitarium
Address [1] 260659 0
124 Pah Road
Royal Oak
Auckland 1023
Country [1] 260659 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286984 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 286984 0
Ethics committee country [1] 286984 0
New Zealand
Date submitted for ethics approval [1] 286984 0
30/06/2011
Approval date [1] 286984 0
27/07/2011
Ethics approval number [1] 286984 0
URA/11/07/031

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

Contacts
Principal investigator
Name 33983 0
Ms Sarah Eady
Address 33983 0
Plant & Food Research
PO Box 4704
Christchurch 8140
New Zealand
Country 33983 0
New Zealand
Phone 33983 0
64 3 325 9671
Fax 33983 0
Email 33983 0
[email protected]
Contact person for public queries
Name 17230 0
Sarah Eady
Address 17230 0
Plant & Food Research
Gerald Street
Lincoln
Christchurch 8074
New Zealand
Country 17230 0
New Zealand
Phone 17230 0
64 3 325 9671
Fax 17230 0
64 3 325 2074
Email 17230 0
[email protected]
Contact person for scientific queries
Name 8158 0
Sarah Eady
Address 8158 0
Plant & Food Research
Gerald Street
Lincoln
Christchurch 8074
New Zealand
Country 8158 0
New Zealand
Phone 8158 0
64 3 325 9761
Fax 8158 0
64 3 325 2074
Email 8158 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
No additional documents have been identified.