Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000230954
Ethics application status
Approved
Date submitted
3/03/2011
Date registered
3/03/2011
Date last updated
24/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The NATINATI Study: A single intervention to compare the effects of hazelnut consumption on the acceptance and cardiovascular disease risk factors among Maori and European participants.
Scientific title
A single intervention to compare the effects of consuming 30g of hazelnuts per day for four weeks on the acceptance and cardiovascular disease risk factors among age-, sex- and BMI-matched Maori and European participants.
Secondary ID [1] 259721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for cardiovascular disease 261300 0
Condition category
Condition code
Diet and Nutrition 259447 259447 0 0
Other diet and nutrition disorders
Cardiovascular 259458 259458 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a single intervention, where participants will be asked to consume 30g of hazelnuts daily for four weeks. The study will be carried out to assess the effects of incorporating hazelnuts into the usual diet on blood lipids and lipoproteins, apolipoproteins, hs-CRP, glucose and insulin among Maori and European participants. This study will also examine the effects of repeated exposure to hazelnuts on participants' acceptance.
Intervention code [1] 264146 0
Lifestyle
Intervention code [2] 264155 0
Prevention
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262254 0
Blood lipids and lipoproteins, apolipoproteins. Plasma total cholesterol, HDL-cholesterol and triglyceride concentrations will be measured by enzymatic methods using a Cobas Mira Plus analyser. Plasma LDL-cholesterol concentration will be calculated using the Friedewald formula. Apolipoproteins A1 and B100 concentrations will be determined by immunotubidity using commercial kits from Roche Diagnostics.
Timepoint [1] 262254 0
At baseline and at 4 weeks after intervention commencement.
Secondary outcome [1] 273407 0
Plasma hs-CRP will be measured by using a Cobas Mira Plus Analyser.
Timepoint [1] 273407 0
At baseline and at 4 weeks after intervention commencement.
Secondary outcome [2] 273408 0
Blood glucose and insulin. Plasma glucose will be measured by using a Cobas Mira Plus Analyser. Plasma insulin will be measured by using Elecsys 2010.
Timepoint [2] 273408 0
At baseline and at 4 weeks after intervention commencement.
Secondary outcome [3] 273409 0
Blood pressure will be measured in triplicate using an Omron pressure monitor (Model HEM-907).
Timepoint [3] 273409 0
At baseline and at 4 weeks after intervention commencement.
Secondary outcome [4] 273410 0
Body composition. This will be measured by using a bioelectrical impedance analysis.
Timepoint [4] 273410 0
At baseline and at 4 weeks after intervention commencement.
Secondary outcome [5] 273411 0
Acceptance for hazelnuts. This will be determined by using a 150mm visual analogue scale.
Timepoint [5] 273411 0
At baseline, at 4 weeks after intervention commencement and daily during the exposure period.

Eligibility
Key inclusion criteria
The inclusion criteria are Maori and European males and females aged between 18 and 40 years of age. They should be in good health.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are smokers. Pregnant or breastfeeding women. People who have asthma, food allergies or food aversions to nuts. People who have familial or secondary hyperlipidaemia or major chronic diseases such as cancer, heart disease or diabetes. People who are taking medication known to affect blood lipid levels.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 3282 0
New Zealand
State/province [1] 3282 0
Otago

Funding & Sponsors
Funding source category [1] 264602 0
University
Name [1] 264602 0
University of Otago
Country [1] 264602 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 263741 0
None
Name [1] 263741 0
Address [1] 263741 0
Country [1] 263741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260596 0
University of Otago Ethics Committee
Ethics committee address [1] 260596 0
Ethics committee country [1] 260596 0
New Zealand
Date submitted for ethics approval [1] 260596 0
07/03/2011
Approval date [1] 260596 0
23/03/2011
Ethics approval number [1] 260596 0
11/052

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32302 0
Address 32302 0
Country 32302 0
Phone 32302 0
Fax 32302 0
Email 32302 0
Contact person for public queries
Name 15549 0
Dr Alexandra Chisholm
Address 15549 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 15549 0
New Zealand
Phone 15549 0
+64 3 4797514
Fax 15549 0
+64 3 4797958
Email 15549 0
[email protected]
Contact person for scientific queries
Name 6477 0
Dr Alexandra Chisholm
Address 6477 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 6477 0
New Zealand
Phone 6477 0
+64 3 4797514
Fax 6477 0
+64 3 4797958
Email 6477 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
No additional documents have been identified.