Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001259538
Ethics application status
Approved
Date submitted
9/02/2015
Date registered
18/11/2015
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kiwifruit modulation of post-prandial glycaemia and its cognitive effects
Scientific title
In healthy subjects, does the dietary intervention of kiwifruit, compared to a standard breakfast, effectively control blood glucose responses and enhance cognition.
Secondary ID [1] 285141 0
U1111-1157-6554
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia 292725 0
Condition category
Condition code
Diet and Nutrition 293020 293020 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four diets: (1) WeetBix (47.3 g)
(2) WeetBix (47.3 g) + Kiwifruit (200 g)
(3) WeetBix (47.3 g) + Guar gum (10 g)
(4) WeetBix (47.3 g) + Guar gum (10 g) + kiwifruit (200 g)

Duration: Participants were given 15 minutes to consume each breakfast.
Frequency: Participants consumed each breakfast one morning a week, over a period of four weeks. Each breakfast (1-4) was only consumed once by each participant.

The wash out period was one week for each participant, and they were asked to fast for 12 hours before each trial, to eliminate the effects of other food on glucose levels.
Intervention code [1] 293258 0
Prevention
Intervention code [2] 293259 0
Lifestyle
Comparator / control treatment
WeetBix alone.
Control group
Active

Outcomes
Primary outcome [1] 292883 0
Blood glucose concentration
Timepoint [1] 292883 0
Blood glucose was tested at: 0 mins (pre=breakfast - Breakfast was consumed straight after the first blood glucose test). The following blood tests were taken post-breakfast at; 20 mins, 40 mins, 60 mins, 90 mins, 120 mins, 150 mins, and 180 mins.
Secondary outcome [1] 309871 0
Cognitive performance was tested using computer generated tests. The five cognitive measures used were: Choice Reaction Time, Stroop, Trail Making B, Word Recall, and Serial Sevens.
Timepoint [1] 309871 0
The first round of cognitive tests were assessed pre-diet at zero mins. The breakfast was consumed at 15 mins, and the second round of cognitive tests were completed at 90 mins, and the third at 180 mins.

Eligibility
Key inclusion criteria
Non-diabetic
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Fasting blood glucose > 7 mmol/L

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment by advertising the study.
Each subject receives all treatments in random order.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Repeated measures design with four treatments randomised, one per week
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
30/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 6288 0
New Zealand
State/province [1] 6288 0
Manawatu

Funding & Sponsors
Funding source category [1] 289749 0
Government body
Name [1] 289749 0
New Zealand Institute for Plant & Food Research Ltd.
Country [1] 289749 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant and Food Research
Address
Private Bag 11600,
Palmerston North 4442,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288441 0
Commercial sector/Industry
Name [1] 288441 0
Zespri
Address [1] 288441 0
400 Maunganui Rd, Mount Maunganui, Tauranga 3116
Country [1] 288441 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291481 0
Health and Disabilities Ethics Committee
Ethics committee address [1] 291481 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 291481 0
New Zealand
Date submitted for ethics approval [1] 291481 0
Approval date [1] 291481 0
20/08/2014
Ethics approval number [1] 291481 0

Summary
Brief summary
The trial involves 20 subjects who each have to consume one breakfast per week over 4 weeks, in random order. The 4 breakfasts are: (1) weetbix, (2) weetbix + guar gum (a widely used food grade ingredient), (3) weetbix + kiwifruit, and (4) weetbix + kiwifruit + guar gum. They then have to have 7 small diabetic-type finger prick tests of blood glucose over a period of three hours and do three short cognitive tests of brain function.
The aim of the study is to determine whether or not kiwifruit, and kiwifruit interacting with guar gum leads to an attenuation of the glycaemic response that helps sustain cognitive performance several hours after a meal.
Trial website
Trial related presentations / publications
N.A
Public notes

Contacts
Principal investigator
Name 50598 0
Dr John A Monro
Address 50598 0
New Zealand Institute for Plant & Food Research,
Private Bag 11600,
Palmerston North 4442
Country 50598 0
New Zealand
Phone 50598 0
+64 6 3556137
Fax 50598 0
Email 50598 0
[email protected]
Contact person for public queries
Name 50599 0
Dr John A Monro
Address 50599 0
New Zealand Institute for Plant & Food Research,
Private Bag 11600,
Palmerston North 4442
Country 50599 0
New Zealand
Phone 50599 0
+64 6 3556137
Fax 50599 0
Email 50599 0
[email protected]
Contact person for scientific queries
Name 50600 0
Dr John A Monro
Address 50600 0
New Zealand Institute for Plant & Food Research,
Private Bag 11600,
Palmerston North 4442
Country 50600 0
New Zealand
Phone 50600 0
+64 6 3556137
Fax 50600 0
Email 50600 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
EmbaseKiwifruit non-sugar components reduce glycaemic response to co-ingested cereal in humans.2017https://dx.doi.org/10.3390/nu9111195
N.B. These documents automatically identified may not have been verified by the study sponsor.