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Trial registered on ANZCTR


Registration number
ACTRN12610000213044
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
16/03/2010
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of kiwifruit on markers of cardiovascular health in men with high cholesterol levels.
Scientific title
The effects of kiwifruit on markers of metabolic health in men with hypercholesterolaemia.
Secondary ID [1] 1488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 256935 0
Metabolic factors associated with cardiovascular risk 256936 0
ApoE genotype 256937 0
Condition category
Condition code
Cardiovascular 257079 257079 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 257080 257080 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four week run-in period (healthy diet based on the New Zealand food based dietary guidelines, e.g 5 servings of fruit and vegetables per day, etc.) 8-week randomised controlled cross-over study- intervention: 2 green kiwifruit/day + healthy diet (n=80); control: healthy diet + other fruit that they would normally have consumed (n=80); 4 weeks on each with no wash-out period between interventions (phase 1). Followed by a 4-week randomised parallel study- group one: 2 green kiwifruit/day + healthy diet (n=40); group two: 2 gold kiwifruit/day + healthy diet (n=40) (phase 2).
Intervention code [1] 256126 0
Other interventions
Comparator / control treatment
Healthy diet and other fruit they would normally have consumed.
Control group
Active

Outcomes
Primary outcome [1] 257981 0
Serum lipid profiles (serum total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides, high density lipoprotein cholesterol (HDL-C), total cholesterol/HDL-C, apolipoprotein A-1 and apolipoprotein B)
Timepoint [1] 257981 0
Baseline1 (beginning of 4 week run-in period), Baseline2 (4wk), 8, 12 and 16 weeks
Secondary outcome [1] 263519 0
Haemostatic markers including plasma fibrinogen, tissue plasminogen activator activity (tPAact) and plasminogen activator inhibitor 1 activity (PAI-1)) and inflammation (C-reactive protein (CRP))
Timepoint [1] 263519 0
Baseline2 (4wk), 8, 12 and 16 weeks
Secondary outcome [2] 263520 0
Markers of glucose metabolism (plasma glucose, serum insulin)
Timepoint [2] 263520 0
Baseline2 (4wk), 8, 12 and 16 weeks
Secondary outcome [3] 263521 0
Effects of apolipoprotein E (apoE) genotypes on response to dietary interventions
Timepoint [3] 263521 0
16 weeks

Eligibility
Key inclusion criteria
Men; >21 years, non-smokers, serum
LDL-C>3.0mmol/L, serum triglycerides (TG) < 3.0mmol/L, prepared to eat kiwifruit and a frozen dairy product
Minimum age
21 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers, using lipid lowering medication, using supplements or functional foods that will affect lipid concentrations (e.g. sterol enriched spreads), chronic disease e.g. coronary heart disease (CHD), diabetes, cancer, familial hypercholesterolaemia

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)
The person who will determine if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject will be allocated. Allocation will be made by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Phase 1: Random assignment to 1 of 2 treatment sequences using computer generated random number tables. Phase 2: re-randomisation assignment to 1 of 2 treatment sequences using computer generated random number tables.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The kiwifruit intervention will not be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 2535 0
New Zealand
State/province [1] 2535 0

Funding & Sponsors
Funding source category [1] 256632 0
Commercial sector/Industry
Name [1] 256632 0
ZESPRI International Limited, New Zealand
Address [1] 256632 0
400 Maunganui Road
Mount Maunganui
3116
Country [1] 256632 0
New Zealand
Primary sponsor type
University
Name
Massey University Albany
Address
Institute of Food, Nutrition and Human health
Private Bag 102904
North Shore City
0745
Country
New Zealand
Secondary sponsor category [1] 255920 0
None
Name [1] 255920 0
Address [1] 255920 0
Country [1] 255920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258661 0
Massey University Human Ethics Committee (MUHEC): Southern A
Ethics committee address [1] 258661 0
Research Ethics Office
Massey University
Palmerston North
4442
Ethics committee country [1] 258661 0
New Zealand
Date submitted for ethics approval [1] 258661 0
Approval date [1] 258661 0
08/03/2010
Ethics approval number [1] 258661 0
09/76

Summary
Brief summary
The study will investigate whether eating two kiwifruit a day in conjunction with a healthy diet, can lower the cholesterol of men with high cholesterol concentrations.
Trial website
Trial related presentations / publications
Gammon, C. S., Kruger, R., Minihane, A. M., Conlon, C. A., Von von Hurst, P. R. & Stonehouse, W. (2013). Kiwifruit consumption favourably affects plasma lipids in a randomised controlled trial in hypercholesterolaemic men. British Journal of Nutrition, 109 (12), 2208–2218
Public notes

Contacts
Principal investigator
Name 30915 0
Dr Welma Stonehouse
Address 30915 0
CSIRO Animal, Food and Health Sciences, PO Box 10041 Adelaide BC, South Australia, Australia, 5000
Country 30915 0
Australia
Phone 30915 0
+61 8 8303 8919
Fax 30915 0
Email 30915 0
welma.stonehouse@csiro.au
Contact person for public queries
Name 14162 0
Ms Cheryl Gammon
Address 14162 0
Massey University
Institute of Food, Nutrition and Human Health
Albany Campus
Private Bag 102904
North Shore City
0745
Auckland
Country 14162 0
New Zealand
Phone 14162 0
+64 9 443 9755
Fax 14162 0
Email 14162 0
C.Gammon@massey.ac.nz
Contact person for scientific queries
Name 5090 0
Dr Dr Welma Stonehouse
Address 5090 0
CSIRO Animal, Food and Health Sciences, PO Box 10041 Adelaide BC, South Australia, Australia, 5000
Country 5090 0
Australia
Phone 5090 0
+61 8 8303 8919
Fax 5090 0
+61 8 8303 8899
Email 5090 0
welma.stonehouse@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary