Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000713392
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
17/05/2017
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Metabolic effects of consuming carbonated water or kiwifruit on a daily basis over seven-weeks
Scientific title
The effect on healthy adults of consuming a kiwifruit preload on glucose and lipid metabolism
Secondary ID [1] 291898 0
nil
Universal Trial Number (UTN)
U1111-1196-3977
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperinsulinaemia 303190 0
Hyperglycaemia 303191 0
Blood lipids 303192 0
Condition category
Condition code
Diet and Nutrition 302629 302629 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 302717 302717 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a parallel randomized trial of two groups over seven-weeks. One group will consume two gold kiwifruit and 500mL carbonated water as a preload to breakfast each day (consumed within the 30 minutes leading up to breakfast). Prior to the intervention, participants’ normal breakfasts will be characterized by asking them to fill in weighed breakfast records for 7 days. The intervention will involve reducing breakfast by an amount equivalent to the carbohydrate contained in the gold kiwifruit preload. For example, if a person ate two slices of jam on toast for breakfast, one of those slices would be replaced by gold kiwifruit. This strategy may produce measurable benefit to metabolic markers over seven weeks; sufficient time for changes in lipids and glycaemic markers to occur. We will obtain breakfast records and train people how to substitute part of their breakfast with the gold kiwifruit. If the habitual breakfast contains fat, this will be removed propotionately with amount of CHO that is substituted with gold kiwifruit, providing a mechanism by which blood lipids would be affected. To monitor adherence we will record kiwifruit/carbonated water collection visits and obtain diet records during the intervention period. This intervention will be conducted by a postgraduate student with a Master of Science in Human Nutrition as part of her PhD with supervision by senior university and Crown Research Institute staff.
Intervention code [1] 298013 0
Lifestyle
Comparator / control treatment
The comparison group will consume 500 mL carbonated water as a preload to their habitual breakfast each day (consumed within the 30 minutes leading up to breakfast) to encourage compliance, while water is unlikely to have an effect on lipids and glucose.
Control group
Active

Outcomes
Primary outcome [1] 302039 0
Between group difference in fasting plasma insulin concentration, adjusted for baseline, using blood obtained via venipuncture at visits 1, 2, 5, and 6. Plasma insulin will be analysed using a Roche Elecsys electrochemiluminescence immunoanalyser
Timepoint [1] 302039 0
From 0 to 7 weeks
Primary outcome [2] 302040 0
Between group difference in fasting blood glucose concentration, adjusted for baseline, using blood obtained via capillary at visits 1, 2, 5, and 6. Blood glucose will be measured using a Hemocue instrument.
Timepoint [2] 302040 0
From 0 to 7 weeks
Secondary outcome [1] 334603 0
Change in plasma total cholesterol
Timepoint [1] 334603 0
From 0 to 7 weeks
Secondary outcome [2] 334604 0
Change in plasma triglycerides
Timepoint [2] 334604 0
From 0 to 7 weeks
Secondary outcome [3] 334605 0
Change in plasma uric acid
Timepoint [3] 334605 0
From 0 to 7 weeks
Secondary outcome [4] 334606 0
Change in plasma metabolomics
Timepoint [4] 334606 0
From 0 to 7 weeks

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
fasting glucose level above the normal range (>6.0mmol/L)
a BMI >30kg/m2
have had gastrointestinal surgical procedures
have a known allergy to kiwifruit
females who are pregnant

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)
A biostatistician will randomise treatments and place these in sealed envelopes. Each time a new participant presents, the investigator will take the next envelope and open it to reveal the group allocation.
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 40 participants (20 per group) would be required to detect a clinically meaningful difference of 1 standard deviation in plasma glucose and insulin concentration with 80% power and a significance level of 0.05

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/05/2017
Actual
Date of last participant enrolment
Anticipated
27/06/2017
Actual
Date of last data collection
Anticipated
29/09/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8890 0
New Zealand
State/province [1] 8890 0
Otago

Funding & Sponsors
Funding source category [1] 296400 0
Government body
Name [1] 296400 0
High Value Nutrition
Country [1] 296400 0
New Zealand
Primary sponsor type
Government body
Name
Plant & Food Research Limited
Address
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 295341 0
University
Name [1] 295341 0
University of Otago
Address [1] 295341 0
Department of Human Nutrition
PO Box 56
Dunedin 9054
Country [1] 295341 0
New Zealand
Secondary sponsor category [2] 295343 0
Commercial sector/Industry
Name [2] 295343 0
Zespri International Ltd
Address [2] 295343 0
PO Box 4043
Mount Maunganui South
400 Maunganui Road
Mount Maunganui 3116
New Zealand
Country [2] 295343 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297629 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 297629 0
Human Ethics Committee
PO Box 56
Dunedin
9054
Ethics committee country [1] 297629 0
New Zealand
Date submitted for ethics approval [1] 297629 0
10/04/2017
Approval date [1] 297629 0
23/04/2017
Ethics approval number [1] 297629 0
H17/048

Summary
Brief summary
Kiwifruit preloads to breakfast have been found to acutely modify the postprandial blood glucose response compared with a non-preload condition. Our aim is to test whether there is a longer-term effect of kiwifruit preload on metabolic markers over 7-weeks. The intervention group will consume 2 kiwifruit and a 500mL bottle of carbonated water 30 min prior to the remainder of breakfast whilst the control group will consume carbonated water in the 30min prior to breakfast. Main outcomes will be differences in fasting plasma glucose and insulin between groups adjusted for baseline. Secondary outcomes will be differences in fasting lipids and uric acid between groups adjusted for baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74646 0
Dr Bernard Venn
Address 74646 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 74646 0
New Zealand
Phone 74646 0
+6434795068
Fax 74646 0
Email 74646 0
[email protected]
Contact person for public queries
Name 74647 0
John Monro
Address 74647 0
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North
4474
Country 74647 0
New Zealand
Phone 74647 0
+646953 7700
Fax 74647 0
Email 74647 0
[email protected]
Contact person for scientific queries
Name 74648 0
John Monro
Address 74648 0
Food Industry Science Centre
Fitzherbert Science Centre
Batchelar Road
Palmerston North
4474
Country 74648 0
New Zealand
Phone 74648 0
+646953 7700
Fax 74648 0
Email 74648 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 372897-(Uploaded-21-04-2021-06-42-09)-Basic results summary.xlsx

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMetabolic and Blood Pressure Effects of Consuming Two Kiwifruit Daily for 7 Weeks: A Randomised Controlled Trial.2022https://dx.doi.org/10.3390/nu14132678
N.B. These documents automatically identified may not have been verified by the study sponsor.