Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000213640
Ethics application status
Approved
Date submitted
13/02/2014
Date registered
27/02/2014
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is nut-enriched bread an acceptable and effective vehicle for improving satiety and blood glucose response?
Scientific title
A randomised controlled crossover intervention to compare the effects of different types of nut-enriched bread on glycaemic response, satiety and acceptance in healthy volunteers
Secondary ID [1] 284094 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic response 291167 0
Condition category
Condition code
Diet and Nutrition 291501 291501 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised controlled crossover study with 4 arms:

Arm 1: Control bread
Arm 2: Finely sliced hazelnut bread
Arm 3: Hazelnut flour bread
Arm 4: Combined finely sliced hazelnut and hazelnut flour bread

This study will be carried out to assess the effects of the 4 different breads on glycaemic response, satiety and acceptance. Participants will be assigned in random order to recieve the 4 treatments. There will be a 1-week washout between treatments
Each bread treatment phase will last 8 days. On days 1 and 8 participants will consume the amount of bread equivalent to that containing 50g of available carbohydrate in order to measure glycaemic response. On day 2 participants will consume the amount they would usually consume for breakfast in order to perform the satiety testing. On days 3-7 participants will consume 120 g of bread and will measure their 'overall liking' and 'desire to consume' the bread.
On days 1 and 8 participants will consume the bread at the research centre. On days 2-7 participants will consume the bread at home. Each day participants will complete a tick list on how they consumed the bread to measure compliance. Participants will be sent reminder text to enhance compliance.
Intervention code [1] 288787 0
Prevention
Comparator / control treatment
The control bread will be made with the same recipe as the nut-enriched bread, but will not contain nuts.
Control group
Placebo

Outcomes
Primary outcome [1] 291475 0
Glycaemic response will be measured by taking finger prick blood samples at baseline and at 15, 30, 45, 60 90, 120 minutes after consuming the bread for analysis of blood glucose. Area under the curve and glycaemic index will be calculated.Each bread will be measured in duplicate.
Timepoint [1] 291475 0
Glycaemic Index will be measured over a 2 hour period following bread consumption on day 1 and day 8
Secondary outcome [1] 306856 0
Satiety will be measured using a 150mm visual analogue scale
Timepoint [1] 306856 0
Satiety will be tested at hourly intervals up to three hours following bread consumption on day 2 of the protocol
Secondary outcome [2] 306857 0
Acceptance will be measured on days 3-7 of the protocol using a 150mm visual analogue scale. Participants will rate their "overall liking" and "desire to consume" the bread.
Timepoint [2] 306857 0
Acceptance will be measured:
1. In a laboratory setting immediately before and at the completion of the intervention period.

2. In a free living situation over a 5 day period of consuming each of the breads as recored on a daily basis by participants completing visual analogue scales rate their "overall liking" and "desire to consume" the bread .

Eligibility
Key inclusion criteria
Healthy males and females aged 18-65 inclusive who are currently consuming at least 3 slices of bread.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with diabetes mellitus
People with disorders of carbohydrate metabolism
People with intolerances or allergies to nuts or bread
Pregnant or lactacting females

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)
Allocation concealment will be used. This will be achieved through allocation being performed by a research assistant who will have no involvement in the enrolment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed 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 administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcomes will be modelled using mixed models with random participant and random participant-intervention effects to accommodate the two levels of repeated measures. All analyses will be performed using Stata 12.1 or a later version and all tests will be performed at the two-sided 0.05 level.
In order to detect moderate to large differences in GI values between any two arms of the trial (0.6 SD, equivalent to differences in GI values of 12.6 based on a SD of 21 for white bread from Venn et al. and assuming an ICC of 0.3 for the two repeated measures at each time point (based on a conservative rounding upwards of an ICC of 0.27 for white bread from Williams et al., 29 participants would be needed to provide 80% power when using a two-sided test at the 0.05 level. In order to allow for 10% loss of data to attrition, 33 participants would be needed at the start of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2014
Actual
27/02/2014
Date of last participant enrolment
Anticipated
5/03/2014
Actual
19/03/2014
Date of last data collection
Anticipated
Actual
29/05/2014
Sample size
Target
33
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 5823 0
New Zealand
State/province [1] 5823 0
Otago

Funding & Sponsors
Funding source category [1] 288723 0
University
Name [1] 288723 0
University of Otago Research Grant
Country [1] 288723 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 287424 0
None
Name [1] 287424 0
Address [1] 287424 0
Country [1] 287424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290561 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 290561 0
Ethics committee country [1] 290561 0
New Zealand
Date submitted for ethics approval [1] 290561 0
Approval date [1] 290561 0
27/01/2014
Ethics approval number [1] 290561 0
H14/004

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

Contacts
Principal investigator
Name 46254 0
Dr Rachel Brown
Address 46254 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 46254 0
New Zealand
Phone 46254 0
+64 3 479 5839
Fax 46254 0
Email 46254 0
[email protected]
Contact person for public queries
Name 46255 0
Rachel Brown
Address 46255 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 46255 0
New Zealand
Phone 46255 0
+64 3 479 5839
Fax 46255 0
Email 46255 0
[email protected]
Contact person for scientific queries
Name 46256 0
Rachel Brown
Address 46256 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 46256 0
New Zealand
Phone 46256 0
+64 3 479 5839
Fax 46256 0
Email 46256 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
EmbaseNut-enriched bread is an effective and acceptable vehicle to improve regular nut consumption.2016https://dx.doi.org/10.1007/s00394-015-1038-3
N.B. These documents automatically identified may not have been verified by the study sponsor.