ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

PIPS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Satiety

Condition category

Condition code

Diet and Nutrition

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]

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]

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]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3125 - Burwood

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Exercise and Nutrition Sciences

Address [1]

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125

Country [1]

Australia

Funding source category [2]

University

Name [2]

CASS Food Research Centre

Address [2]

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125

Country [2]

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]

Individual

Name [1]

Dr Shirani Gamlath

Address [1]

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Research Ethics, Deakin University
221 Burwood Hwy, Burwood, VIC, 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/01/2021

Approval date [1]

18/03/2021

Ethics approval number [1]

2021-028

Summary

Brief summary

High protein diets are effective at helping individuals maintain a healthy weight due to being highly satiating compared to other macronutrients. Supplementing protein into staple foods that are easily affordable, such as bread, is an easy way to incorporate added protein into a diet. However, it is difficult to recommend increasing protein intake at a population level because current farming practises that produce high-protein products from livestock are not sustainable, especially when considering climate change and increasing populations worldwide.
Due to this, high-protein products made from livestock are becoming more expensive and less attainable. Proteins produced from sources other than livestock, such as plants and insects, are becoming more favourable as their production has a lower ecological footprint. However, the satiating effects of proteins are not necessarily equal, and it is unclear whether proteins from plants and insects are able to add a significant satiating effect when supplemented into staple foods. This study will assess the satiating effects plant and insect proteins within a staple food product compared to proteins derived from livestock. 

Participation in this study will involve attending four 30-minute morning sessions at the CASS Food Research Centre in Deakin University Burwood Campus. 

Before each session, participants will:
•	Need to fast for at least 10 hours (overnight). 

During each session, participants will:
•	Have their height and weight assessed (this will only occur during the first session).
•	Be provided with a moderate serving of bread which will be based on their estimated energy requirements which they will need to eat in its entirety.
•	Complete questionnaires about their liking of the bread and their appetite (approx. 2 minutes).

After each session, participants will:
•	Complete additional appetite questionnaires every 30 minutes over the next 3 hours (approx. 2 minutes each). 
•	Refrain from eating, drinking anything other than water, or doing any moderate to vigorous physical activity during this 3-hour period.

Trial website

https://www.cassfood.com.au/about/our-current-studies/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Costanzo

Address

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 9246 8207

Fax

andrew.costanzo@deakin.edu.au

Contact person for public queries

Name

Andrew Costanzo

Address

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 9246 8207

Fax

andrew.costanzo@deakin.edu.au

Contact person for scientific queries

Name

Andrew Costanzo

Address

School of Exercise and Nutrition Sciences, Deakin University
221 Burwood Hwy, Burwood, VIC 3125

Country

Australia

Phone

+61 3 9246 8207

Fax

andrew.costanzo@deakin.edu.au

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 andrew.costanzo@deakin.edu.au

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.

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