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Trial registered on ANZCTR


Registration number
ACTRN12616000858493
Ethics application status
Approved
Date submitted
8/06/2016
Date registered
30/06/2016
Date last updated
30/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial on the effect of the consumption of gold kiwifruit on glycaemic control in individuals with prediabetes
Scientific title
Effect of the consumption of gold kiwifruit on glycaemic control in individuals with prediabetes
Secondary ID [1] 289397 0
NIL
Universal Trial Number (UTN)
U1111-1183-9874
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 299058 0
Dysglycaemia 299059 0
Condition category
Condition code
Metabolic and Endocrine 299098 299098 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be asked to consume 2 gold kiwifruit (flesh only) with their breakfast every day for 12 weeks. Adherence will be monitored by food diaries and by measurement of vitamin c in blood samples.
Intervention code [1] 294982 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298565 0
HbA1c will be determined in EDTA blood using Biorad Variant HPLC
Timepoint [1] 298565 0
13 weeks
Secondary outcome [1] 324594 0
Fasting glucose will be determined in plasma using the glucose hexokinase enzymatic assay on the Abbott C series analyser.
Timepoint [1] 324594 0
13 weeks
Secondary outcome [2] 325208 0
Lipid parameters (total cholesterol (TC), HDL-cholesterol (HDL), LDL-cholesterol (LDL) and triglycerides (TG))
Timepoint [2] 325208 0
13 weeks
Secondary outcome [3] 325209 0
Gastrointestinal symptom rating scale (GSRS).
Timepoint [3] 325209 0
Weeks 7 and 13
Secondary outcome [4] 325210 0
Hormones (for example, insulin, leptin, ghrelin and adiponectin)
Timepoint [4] 325210 0
13 weeks
Secondary outcome [5] 325211 0
Gut microbiota composition
Timepoint [5] 325211 0
13 weeks

Eligibility
Key inclusion criteria
Inclusion criteria: Selection criteria for trial participants will be the requirement to meet the diagnostic criteria for prediabetes according to the American Diabetes Association (ADA) criteria for glycated haemoglobin (HbA1c). All participants will be free living and required to maintain their normal dietary and lifestyle habits for the duration of the trial.
ADA criteria for the diagnosis of prediabetes: HbA1c: 39-46 mmol/mol inclusive.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
a.Individuals unable to give informed consent.
b. Those with an HbA1c outside the range of 39-46 mmol/mol.
c. Those with a previous diagnosis of diabetes.
d. Those on diabetes medications such as Metformin.
e.Those that have taken antibiotics within a month prior to the trial starting.
f.Those with a known kiwifruit allergy.
g.Those with a medical history of significant gastrointestinal disease for example, coeliac disease, inflammatory bowel disease or a previous bowel resection.
h.Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post selection (trial period) will be excluded.
i.Those who have a planned trip overseas in the 3 months post selection will be excluded.

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)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a pilot exploratory study. Summary statistics (mean, SD, SEM, 95% CI) will be reported for all continuous variables. Median (plus interquartile range) will be reported for non-normally distributed data, and categorical variables, such as low or high diversity among gut microbial species, will be presented as numbers and percentages. Comparisons of baseline and end of study measures, such as HbA1c, will be made to determine if there are any statistical and clinical differences.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7945 0
New Zealand
State/province [1] 7945 0
Canterbury

Funding & Sponsors
Funding source category [1] 293772 0
Commercial sector/Industry
Name [1] 293772 0
Zespri International Ltd
Address [1] 293772 0
40 Maunganui Road
Mt Maunganui
New Zealand 3116
Country [1] 293772 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin, 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292600 0
None
Name [1] 292600 0
Address [1] 292600 0
Country [1] 292600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295208 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 295208 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
P O Box 5013
Wellington 6011
Ethics committee country [1] 295208 0
New Zealand
Date submitted for ethics approval [1] 295208 0
09/06/2016
Approval date [1] 295208 0
15/06/2016
Ethics approval number [1] 295208 0
16/STH/87

Summary
Brief summary
The purpose of this study is to determine if consumption of two gold kiwifruit per day for 12 weeks favourably alters gut microbiota composition without adversely affecting blood glucose control in people with pre-diabetes..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66518 0
Prof Richard Gearry
Address 66518 0
Department of Medicine
University of Otago Christchurch Campus
2 Riccarton Avenue
P O Box 4345
Christchurch 8011
Country 66518 0
New Zealand
Phone 66518 0
+64 3 3640 530
Fax 66518 0
+64 3 3640 525
Email 66518 0
richard.gearry@cdhb.health.nz
Contact person for public queries
Name 66519 0
Miss Renee Wilson
Address 66519 0
Don Beaven Medical Research Centre,
Christchurch Hospital Campus,
Level 2, 40 Stewart Street
Private Bag 4710,
Christchurch 8140
Country 66519 0
New Zealand
Phone 66519 0
+64 3 3640 449
Fax 66519 0
+64 3 3640 457
Email 66519 0
renee.wilson@postgrad.otago.ac.nz
Contact person for scientific queries
Name 66520 0
Miss Renee Wilson
Address 66520 0
Don Beaven Medical Research Centre,
Christchurch Hospital Campus,
Level 2, 40 Stewart Street
Private Bag 4710,
Christchurch 8140
Country 66520 0
New Zealand
Phone 66520 0
+64 3 3640 449
Fax 66520 0
+64 3 3640 457
Email 66520 0
renee.wilson@postgrad.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results