Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000939493
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
15/07/2016
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of long-term consumption of kiwifruit on risk factors for disease in healthy subjects.
Scientific title
Effect of long-term ingestion of kiwifruit on metabolic outcomes in healthy subjects: A single blinded randomised cross-over pilot study
Secondary ID [1] 289381 0
Nil
Universal Trial Number (UTN)
U1111-1184-0263
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidaemia 299019 0
Diabetes 299024 0
Inflammation 299025 0
Oxidative stress 299026 0
Condition category
Condition code
Cardiovascular 299077 299077 0 0
Coronary heart disease
Metabolic and Endocrine 299080 299080 0 0
Diabetes
Inflammatory and Immune System 299081 299081 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is six weeks of consuming two 'SunGold' kiwifruit per day as part of the customary diet, with the exclusion of vitamin supplements. The control treatment is the customary diet with the exclusion of kiwifruit and vitamin supplements. For all participants there is a three week kiwifruit-free lead in period, a three week kiwifruit-free wash out period at cross-over, and a three week kiwifruit free follow up at the end of the second intervention.

Kiwifruit consumption will be monitored and recorded during weekly delivery of kiwifruit.,to subjects
Intervention code [1] 294968 0
Prevention
Intervention code [2] 294969 0
Lifestyle
Comparator / control treatment
Six weeks consuming customary diet with no kiwifruit
Control group
Active

Outcomes
Primary outcome [1] 298550 0
Plasma lipid profile: HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides.
Timepoint [1] 298550 0
Samples will be taken at the end of three weeks lead in, six weeks after starting to consume 2 kiwifruit per day (intervention 1), after three weeks washout, after six weeks of intervention 2, and after three weeks follow up.
Primary outcome [2] 298551 0
HbA1c concentration in blood
Timepoint [2] 298551 0
Samples will be taken at the end of three weeks lead in, six weeks after starting to consume 2 kiwifruit per day (intervention 1), after three weeks washout, after six weeks of intervention 2, and after three weeks follow up.
Secondary outcome [1] 324552 0
Change in food intakes as a result of consuming 2 kiwifruit per day assessed by a three day food diary
Timepoint [1] 324552 0
At the end of three weeks lead in, six weeks after starting to consume 2 kiwifruit per day (intervention 1), after three weeks washout, after six weeks of intervention 2, and after three weeks follow up.
Secondary outcome [2] 324553 0
Inflammatory biomarkers: C-reactive protein, TNF-a, IL-6 will be measured in plasma samples
Timepoint [2] 324553 0
Samples will be taken at the end of three weeks lead in, six weeks after starting to consume 2 kiwifruit per day (intervention 1), after three weeks washout, after six weeks of intervention 2, and after three weeks follow up.
Secondary outcome [3] 324554 0
Biomarkers of oxidative stress: Total antioxidant capacity, superoxide dismutase, nitric oxide synthase and lactate dehydrogenase will be measured in plasma.
Timepoint [3] 324554 0
Samples will be taken at the end of three weeks lead in, six weeks after starting to consume 2 kiwifruit per day (intervention 1), after three weeks washout, after six weeks of intervention 2, and after three weeks follow up.

Eligibility
Key inclusion criteria
Good health.
No intolerance of kiwifruit.
BMI 20-35 kg/m2
Age 20-60 years.
Willingness to comply with demands of the trial.
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intolerance of kiwifruit.
Ill health
Glucose intolerance.

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 coded by independent person so that identity of subjects unknown to allocator at time of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated randomisation table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Intervention-free lead-in, washout at cross-over, and intervention-free follow up included in design.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on analysis of data in Stanhope et al (2009) Consuming fructose-sweetened, not glucose-sweetened beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans J. Clin. Invest. 119, 1322-1334.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/07/2016
Date of last participant enrolment
Anticipated
18/07/2016
Actual
15/07/2016
Date of last data collection
Anticipated
10/12/2016
Actual
13/12/2016
Sample size
Target
26
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7944 0
New Zealand
State/province [1] 7944 0
Manawatu

Funding & Sponsors
Funding source category [1] 293767 0
Government body
Name [1] 293767 0
New Zealand Institute for Plant & Food Research Limited
Country [1] 293767 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant & Food Research Limited
Address
Private Bag 11 600
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 292597 0
None
Name [1] 292597 0
Address [1] 292597 0
Country [1] 292597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295203 0
Health and Disability Ethics Committee
Ethics committee address [1] 295203 0
Ministry of Health,
PO Box 5013
Wellington 6140
Ethics committee country [1] 295203 0
New Zealand
Date submitted for ethics approval [1] 295203 0
13/06/2016
Approval date [1] 295203 0
24/06/2016
Ethics approval number [1] 295203 0
16/STH/89

Summary
Brief summary
A pilot study of the metabolic effects of long term consumption of SunGold kiwifruit in healthy subjects. The primary hypothesis is that two kiwifruit consumed daily for six weeks will not have any harmful effect as measured by risk factors for cardiovascular disease. The purpose of the study is to establish whether or not the increased intake of fructose and glucose resulting from daily ingestion of two kiwifruit could lead to harmful metabolic change, or exposure to glycaemia. Conversely, whether the increase in Vitamin C and other phytochemicals as a result of consuming kiwifruit could protect against the processes of inflammation and oxidation that lead to long term damage will also be investigated by measuring changes in several biomarkers indicative of inflammation and oxidation in the kiwifruit versus non-kiwifruit groups.
The study will employ a randomised cross-over design in which all subjects ingest two kiwifruit per day or no kiwifruit (their normal diet minus kiwifruit) for six weeks. There will be a kiwifruit-free lead in period of three weeks, a three week washout at cross over, and a kiwifruit-free follow up of three weeks. Blood samples will be taken five times from all subjects: at the end of lead in, after intervention 1, after washout, at the end of intervention 2, and at the end of the follow up.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 953 953 0 0
/AnzctrAttachments/370855-KRIP LT Protocol 7 June DONE .docx
Attachments [2] 954 954 0 0
/AnzctrAttachments/370855-KRIP LT- Participant info sheet DONE.docx

Contacts
Principal investigator
Name 66478 0
Dr John Alexander Monro
Address 66478 0
The New Zealand Institute for Plant & Food Research Limited
Private Bag 11600,
Palmerston North 4442
Country 66478 0
New Zealand
Phone 66478 0
+64 6 355 6137
Fax 66478 0
+64 6 351 7050
Email 66478 0
[email protected]
Contact person for public queries
Name 66479 0
Dr John Monro
Address 66479 0
The New Zealand Institute for Plant & Food Research Limited
Private Bag 11600,
Palmerston North 4442
Country 66479 0
New Zealand
Phone 66479 0
+64 6 355 6137
Fax 66479 0
+64 6 351 7050
Email 66479 0
[email protected]
Contact person for scientific queries
Name 66480 0
Dr John Monro
Address 66480 0
The New Zealand Institute for Plant & Food Research Limited
Private Bag 11600,
Palmerston North 4442
Country 66480 0
New Zealand
Phone 66480 0
+64 6 355 6137
Fax 66480 0
+64 6 351 7050
Email 66480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.