Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000222549
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
9/03/2015
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised repeated measures dietary intervention study to measure the effect of “Hayward” and “Sungold” kiwifruit on postprandial blood glucose (glycaemic) response relative to the response to a glucose reference dose, and the effect on glycaemic response of equi-carbohydrate partial exchange of kiwifruit for breakfast cereal, in healthy adult subjects.
Scientific title
A randomised repeated measures dietary intervention study to measure the effect of “Hayward” and “Sungold” kiwifruit on postprandial blood glucose (glycaemic) response relative to the response to a glucose reference dose, and the effect on glycaemic response of equi-carbohydrate substitution of kiwifruit for breakfast cereal, in healthy adult subjects.
Secondary ID [1] 285867 0
Nil
Universal Trial Number (UTN)
U1111-1163-4351
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemia 293780 0
Condition category
Condition code
Diet and Nutrition 294087 294087 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 294408 294408 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will each consume six diets in random order, with at least two days between diets. The diets will be:
1. Glucose (reference) 40 g dissolved in water,
2. Weet Bix (amount providing 40 g available carbohydrate)
3. Gold kiwifruit (200 g, containing about 20 g cabohydrate)
4. Green kiwifruit (200 g, containing about 20 g cabohydrate)
5. Weet-Bix substituted on an equal glycaemic carbohydrate basis by 200 g “Hayward” kiwifruit (Total carbohydrate intake 40 g; Kiwifruit 200 g, Weet-Bix 30.9 g, water 120 ml)
6. Weet-Bix substituted on an equal glycaemic carbohydrate basis by 200 g “Sungold” kiwifruit (Total carbohydrate intake 40 g; Kiwifruit 200 g, Weet-Bix 27.06 g, water 120 ml).

Subjects will be asked to consume diets after an overnight fast and the blood glucose response to the diets will be measured as changes from baseline in blood glucose concentrations measured by finger-prick capillary blood glucose analysis. The procedure is standard in measurement of the glycaemic index of foods. The subjects will consume two diets per week over a period of three weeks.
Intervention code [1] 290845 0
Treatment: Other
Comparator / control treatment
Glucose reference (40 g)
Control group
Active

Outcomes
Primary outcome [1] 293873 0
To determine the relative glycaemic potency of “Hayward” and “Sungold” kiwifruit by finger prick blood glucose analysis
Timepoint [1] 293873 0
Measured twice weekly for three weeks.
Blood glucose concentrations will be measured 15, 30, 45, 60, 90, 120 and 180 minutes after consuming the food.
Secondary outcome [1] 312049 0
Determine the glycaemic index of "Hayward" and "Sungold" kiwifruit by finger prick blood glucose analysis
Timepoint [1] 312049 0
Measured twice weekly for three weeks.
Blood glucose concentrations will be measured 15, 30, 45, 60, 90, 120 and 180 minutes after consuming the food.

Eligibility
Key inclusion criteria
1. Subject between the ages of 18 and 65.
2. Subjects healthy adjudged by GHQ, past history, blood glucose response and HbA1c level.
3. Tolerant to kiwifruit.
4. Willing to adhere to the requirements of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Intolerance of kiwifruit
2. Glucose intolerance or HbA1c above the normal range.

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)
Subjects will be recruited by email and flyer, followed by an interview and explanation of the study. They will be provided with the information sheet to read. Those who would like to take part in the study will be asked to sign the informed consent form and then further screened for immediate glucose tolerance by response to an oral glucose dose, and evidence of long term glucose intolerance by measurement of HbA1c levels.
The subjects will be assigned an identification number, including those who fail the screening procedure.
Subjects who pass the screening procedure will be allocated numbers.

Each subject received all treatments in random order. The recruiter was unaware of the treatment order for each individual at time of recruiting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the diets for each subject (n=15-20) will be determined by 15-20 computer randomisations of the numbers 1-6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Randomised, repeated measures
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Groups will be compared in terms of response amplitude, time to baseline and incremental area under the blood glucose response curve by comparison of treatments. A registered statistician at Plant & Food Research will conduct the statistical analysis.
Subject numbers were based on the number specified in the standard protocol for GI determination and on a recent trial of the effects of kiwifruit on blood glucose in which n = 20 was enough to detect significant differences between diets.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/12/2014
Actual
5/01/2015
Date of last participant enrolment
Anticipated
30/01/2015
Actual
30/01/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 6555 0
New Zealand
State/province [1] 6555 0
Manawatu

Funding & Sponsors
Funding source category [1] 290447 0
Commercial sector/Industry
Name [1] 290447 0
Zespri International Limited
Country [1] 290447 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant & Food Research Limited
Address
Private Bag 11600
Palmerston North 4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289153 0
Commercial sector/Industry
Name [1] 289153 0
Zespri International Limited
Address [1] 289153 0
400 Maunganui Rd,
Mt Maunganui, 3116
New Zealand
Country [1] 289153 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292121 0
Health and Disability Ethics Committee
Ethics committee address [1] 292121 0
1 The Terrace,
C/- MEDSAFE, Level 6, Deloitte House,
10 Brandon Street,
PO Box 5013,
Wellington 6011
Ethics committee country [1] 292121 0
New Zealand
Date submitted for ethics approval [1] 292121 0
Approval date [1] 292121 0
10/12/2014
Ethics approval number [1] 292121 0
14/CEN/207

Summary
Brief summary
This is a randomised repeated measures trial in which the interventions are a glucose reference, “Hayward” and “Sungold” kiwifruit, WeetBix breakfast cereal, and the breakfast cereal partially substituted by kiwifruit. The subjects (n = 15-20) will each receive all treatments with at least two days between treatments. They will be asked to consume each diet after an overnight fast and capillary blood glucose samples will be taken at intervals over a three hour period to allow a blood glucose response curve to be established, from which several characteristics of the response will be determined.
Trial website
Trial related presentations / publications
There are no trial-related citations
Public notes

Contacts
Principal investigator
Name 53614 0
Dr John A Monro
Address 53614 0
New Zealand Institute for Plant & Food Research Limited,
Private Bag 11600,
Palmerston North 4442
Country 53614 0
New Zealand
Phone 53614 0
+64-6-3556137
Fax 53614 0
+64-6-3517050
Email 53614 0
[email protected]
Contact person for public queries
Name 53615 0
Dr Juliet Ansell
Address 53615 0
Zespri International Limited
400 Maunganui Rd,
Mt Maunganui

PO Box 4043, Mt Maunganui 3149
Country 53615 0
New Zealand
Phone 53615 0
+64 7 572 7798
Fax 53615 0
+64 7 574 8031
Email 53615 0
[email protected]
Contact person for scientific queries
Name 53616 0
Dr John A Monro
Address 53616 0
New Zealand Institute for Plant & Food Research Limited,
Private Bag 11600,
Palmerston North 4442
Country 53616 0
New Zealand
Phone 53616 0
+64-6-3556137
Fax 53616 0
+64-6-3517050
Email 53616 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
EmbaseEquicarbohydrate partial exchange of kiwifruit for wheaten cereal reduces postprandial glycaemia without decreasing satiety.2016https://dx.doi.org/10.1017/jns.2016.30
Dimensions AIKiwifruit Exchanges for Increased Nutrient Richness with Little Effect on Carbohydrate Intake, Glycaemic Impact, or Insulin Response2018https://doi.org/10.3390/nu10111710
N.B. These documents automatically identified may not have been verified by the study sponsor.