Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000625572
Ethics application status
Approved
Date submitted
4/02/2024
Date registered
14/05/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
14/05/2024
Date results information initially provided
14/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of polyphenol-enriched bread on postprandial glycaemic response in healthy adults
Scientific title
Effects of polyphenol-enriched bread on postprandial glycaemic response in healthy adults
Secondary ID [1] 311462 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 332782 0
Condition category
Condition code
Diet and Nutrition 329500 329500 0 0
Obesity
Metabolic and Endocrine 329501 329501 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design: Randomised, cross-over, single-blinded study
Treatment: A qualified Researcher A provided bread formulated with 20% spinach extracts (as the source of polyphenols) for breakfast after the participants fasted for at least 10 hours, equivalent to 50 g carbohydrates (~110g total weight). The researcher mentioned above was blinded from the treatment type, but the participants could detect the bread's colour compared with the placebo (white bread), hence single-blinded.
Researcher B performed blinding, who was not involved in collecting blood samples from the participants for sample analysis. Treatment was provided to the participants on a covered serving tray, and participants ate in a quiet room without Researcher A present in the room. Participants are required to consume the bread within 15 minutes, the consumption is monitored with Researcher B present to collect the empty tray. An amount of 600 mL water is provided throughout the 4 hours of the study. For the cross-over trial, at least a 7-day washout period was used for each participant.
This is not an individualised intervention.
Intervention code [1] 327919 0
Prevention
Intervention code [2] 327920 0
Lifestyle
Comparator / control treatment
Control bread was white bread without the addition of spinach at an equivalent weight of 50 g carbohydrates (or ~110g total weight). This bread appears white, not blinded from the participants but blinded from Researcher A, who collects information and blood samples from the participants to be analysed later.
Researcher B performed blinding who was not involved in collecting blood samples from the participants for sample analysis. Treatment was provided to the participants on a covered serving tray, and participants ate in a quiet room without Researcher A present in the room. Participants are required to consume the bread within 15 min, the consumption is monitored with Researcher B present to collect the empty tray and water. An amount of 600 mL water is provided throughout the 4 hours of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 337296 0
area under the curve for glucose level for treatment compared to control
Timepoint [1] 337296 0
0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes, from the start of consuming the treatment bread or white bread. Participants are asked to consume the bread within 15 minutes of the start of consumption.
Primary outcome [2] 338121 0
area under the curve for insulin levels for treatment compared to control
Timepoint [2] 338121 0
0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes, from the start of consuming the treatment bread or white bread. Participants are asked to consume the bread within 15 minutes of the start of consumption.
Secondary outcome [1] 431371 0
hunger, satiety, fullness and readiness to eat will be measured as a composite secondary outcome
Timepoint [1] 431371 0
0, 30, 60, 120 and 180 minutes, from the start of consuming the treatment bread or white bread. Participants are asked to consume the bread within 15 minutes of the start of consumption.

Eligibility
Key inclusion criteria
• 18 years or more
• Fasting blood glucose level between 3.9 mmol/L – 5.5 mmol/L
• Not taking medications that affect blood glucose levels (e.g. diabetic medications)
• No gastrointestinal conditions that may affect glycaemic response (any gastrointestinal inflammatory and/or functional disease/disorder and/or recent gastrointestinal surgery involving any body parts involved in digestion)
• No health conditions that may affect participation (e.g. diabetes, cardiovascular disease, hypertension, liver or thyroid dysfunction or recent major surgery or have implanted cardiac defibrillator)
• Not a present or past cigarette smoker
• Able to adhere to the study protocol and consume every study food
• Available to attend three testing sessions at the Notting Hill BASE Facility
• Nor pregnant, planning on becoming pregnant or breastfeeding
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

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)
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed if it was done by the researcher who is not involved in sample or data collection, where the treatment was supplied using a sealed container. The participants were able to differentiate between treatments due to taste.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/09/2023
Date of last participant enrolment
Anticipated
Actual
13/10/2023
Date of last data collection
Anticipated
Actual
13/12/2023
Sample size
Target
12
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315743 0
University
Name [1] 315743 0
Monash University
Country [1] 315743 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 317857 0
None
Name [1] 317857 0
Address [1] 317857 0
Country [1] 317857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314606 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314606 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314606 0
Australia
Date submitted for ethics approval [1] 314606 0
18/07/2023
Approval date [1] 314606 0
11/09/2023
Ethics approval number [1] 314606 0
26497

Summary
Brief summary
Polyphenols are naturally occurring colourful substances in plant foods, known to reduce blood glucose levels. The aim of this study is to investigate the ability of polyphenols enriched in bread to reduce blood glucose levels in healthy people. The polyphenol-rich extracts from spinach at 1-10% will be added to bread and taste-tested to choose the most accepted concentration for this study. Spinach is one of the vegetables that is versatile and known to contain high polyphenols content, where a cup of raw contains nearly 100 mg of polyphenols and 7x more in frozen products
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132158 0
Dr Elizabeth Barber
Address 132158 0
BASE Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, Clayton Campus, VIC 3800, Australia
Country 132158 0
Australia
Phone 132158 0
+61425802857
Fax 132158 0
Email 132158 0
elizabeth.barber@monash.edu
Contact person for public queries
Name 132159 0
Elizabeth Barber
Address 132159 0
BASE Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, Clayton Campus, VIC 3800, Australia
Country 132159 0
Australia
Phone 132159 0
+61425802857
Fax 132159 0
Email 132159 0
elizabeth.barber@monash.edu
Contact person for scientific queries
Name 132160 0
Elizabeth Barber
Address 132160 0
BASE Facility, Department of Nutrition, Dietetics and Food, Faculty of Medicine, Nursing and Health Sciences, Clayton Campus, VIC 3800, Australia
Country 132160 0
Australia
Phone 132160 0
+61425802857
Fax 132160 0
Email 132160 0
elizabeth.barber@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.