Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000819820
Ethics application status
Approved
Date submitted
26/05/2021
Date registered
28/06/2021
Date last updated
15/06/2022
Date data sharing statement initially provided
28/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of plant and insect proteins on satiety
Scientific title
The effect of plant and insect proteins on satiety in healthy adults
Secondary ID [1] 304273 0
None
Universal Trial Number (UTN)
Trial acronym
PIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Satiety 322002 0
Condition category
Condition code
Diet and Nutrition 319721 319721 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three intervention treatments in this study and one control treatment. Each intervention treatment is the consumption of white bread formulated with added protein. The proteins in each bread are derived from pea, crickets or whey. Each protein will replace 10% of the wheat flour from a standard recipe (see control treatment). There will be a washout period of at least 24 hours between the treatments.

The dose of bread that participants will receive is 9% of their estimated energy requirement, which is calculated based on their age, sex, and habitual physical activity.

Participants will be provided with each treatment on seperate days at the CASS Food Research Centre in Deakin University Burwood. They must consume the portion of bread in its entirety within 30 minutes. Ad libitum intake of water will be allowed. This will be conducted in the presence of the principle researcher, who has 7 years experience in sensory testing in this facility. Participants will be supervised to ensure full consumption of the bread.

Participants will need to have fasted for at least 10 hours prior to their appointments. Compliance to this will be checked verbally as they arrive at the facility, and again digitally during the completion of an appetite questionnaire (discussed in the Outcomes section).
Intervention code [1] 320613 0
Treatment: Other
Comparator / control treatment
The control treatment is the consumption of a standard white bread made using a bread maker according to the manufacturer's suggested recipe (Panasonic SD-2501).

Consumption of the control treatment will occur similarly to the intervention treatments (see above for details).
Control group
Active

Outcomes
Primary outcome [1] 327656 0
Self-reported appetite ratings rating using digital 100 mm visual analague scales including the following constructs: hunger, fullness, prospective consumption, and desire to eat
Timepoint [1] 327656 0
30 min prior to treatment commencement; and 0 min, 30 min, 60 min, 90 min, 120 min (primary timepoint), 150 min & 180 min post treatment completion
Secondary outcome [1] 396123 0
Ratings of acceptability of the treatments using digital 9-point hedonic scales including the acceptability of the bread's appearance, odour, flavour and texture.
Timepoint [1] 396123 0
0 minutes post treatment completion

Eligibility
Key inclusion criteria
Individuals who are: fluent in English; willing to consume products containing wheat, dairy and insects.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inidividuals who are: smokers; pregnant or lactating; allergic and/or intolerant to wheat/gluten, dairy/lactose, and shellfish; following an energy-restricted diet; have an illness or condition that may prevent them from safely overnight fasting (e.g., diabetes mellitus)

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)
Treatments labelled with 3-digit blinding codes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Forty participants was chosen as a sample size due to similar studies in the discipline using a similar number of subjects.
Linear mixed models will be used to assess the effect of treatment over time, including treatment, time and treatment*time interaction as fixed effects, and participant ID is a mixed effect. Area-under-the-curve for each treatment will also be calculated and a one-way ANOVA will be used to compare the overall satiating effect of each treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2021
Actual
6/09/2021
Date of last participant enrolment
Anticipated
30/07/2021
Actual
11/01/2022
Date of last data collection
Anticipated
31/08/2021
Actual
8/02/2022
Sample size
Target
40
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 34165 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 308650 0
University
Name [1] 308650 0
School of Exercise and Nutrition Sciences
Country [1] 308650 0
Australia
Funding source category [2] 308696 0
University
Name [2] 308696 0
CASS Food Research Centre
Country [2] 308696 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Costanzo
Address
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125
Country
Australia
Secondary sponsor category [1] 309580 0
Individual
Name [1] 309580 0
Dr Shirani Gamlath
Address [1] 309580 0
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125
Country [1] 309580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308576 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308576 0
Ethics committee country [1] 308576 0
Australia
Date submitted for ethics approval [1] 308576 0
21/01/2021
Approval date [1] 308576 0
18/03/2021
Ethics approval number [1] 308576 0
2021-028

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

Contacts
Principal investigator
Name 111198 0
Dr Andrew Costanzo
Address 111198 0
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125
Country 111198 0
Australia
Phone 111198 0
+61 3 9246 8207
Fax 111198 0
Email 111198 0
[email protected]
Contact person for public queries
Name 111199 0
Andrew Costanzo
Address 111199 0
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125
Country 111199 0
Australia
Phone 111199 0
+61 3 9246 8207
Fax 111199 0
Email 111199 0
[email protected]
Contact person for scientific queries
Name 111200 0
Andrew Costanzo
Address 111200 0
School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125
Country 111200 0
Australia
Phone 111200 0
+61 3 9246 8207
Fax 111200 0
Email 111200 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The entire cleaned dataset used for analysis including treatment and outcomes for each participant
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator via emailing [email protected]


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.