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Trial registered on ANZCTR


Registration number
ACTRN12611000838910
Ethics application status
Not yet submitted
Date submitted
9/08/2011
Date registered
9/08/2011
Date last updated
9/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Nuts2 Study: The effect of daily consumption of raw versus roasted/salted hazelnuts on Cardiovascular disease risk factors and acceptability in Maori and European populations
Scientific title
A randomised, cross over intervention study to compare the acceptability and effects of incorporating 30 grams per day of whole, raw or roasted/salted hazelnuts on blood lipids, lipoproteins, apolipoproteins, alpha-tocopherol, Hs-CRP, glucose, body weight and composition and blood pressure in healthy Maori and European populations.
Secondary ID [1] 262803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for cardiovascular disease 270509 0
Condition category
Condition code
Diet and Nutrition 270672 270672 0 0
Other diet and nutrition disorders
Cardiovascular 270673 270673 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, cross over intervention study, with two arms which looks at the effect of regularly eating 30 grams of whole, raw or lightly roasted and salted hazelnuts on cardiovascular disease risk factors including blood cholesterol (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, apolipoproteins) and consumers’ acceptability. The effects of hazelnut consumption on biomarkers (alpha-tocopherol, Hs-CRP, glucose, body composition and blood pressure) of heart disease will also be examined. This study will also compare the acceptability and health effects of regular nut consumption between Maori and European reflective of the general population. After a two-week run-in period, participants will be allocated to receive 30 grams of raw hazelnuts per day or 30 grams of lightly roasted and salted hazelnuts per day in random order. Each treatment will be of four weeks duration with a two-week washout between each treatment. Participants will be consuming the different forms of hazelnuts for a total of eight weeks. The study will be of 12-weeks duration.
Intervention code [1] 269148 0
Lifestyle
Intervention code [2] 269153 0
Prevention
Comparator / control treatment
Daily consumption of 30 grams of raw hazelnuts will be compared to the daily consumption of lightly roasted and salted hazelnuts
Control group
Active

Outcomes
Primary outcome [1] 269390 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] 269390 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.
Secondary outcome [1] 287530 0
Plasma alpha-tocopherol will be measured using the Agilent HPL-C system (1100 series). Plasma Hs-CRP will be measured by using a Cobas Mira Plus Analyser.
Timepoint [1] 287530 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.
Secondary outcome [2] 287531 0
Blood glucose. Plasma glucose will be measured by using a Cobas Mira Plus Analyser.
Timepoint [2] 287531 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.
Secondary outcome [3] 287532 0
Blood pressure will be measured in triplicate using an Omron pressure monitor (Model HEM-907).
Timepoint [3] 287532 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.
Secondary outcome [4] 287533 0
Body composition. This will be measured by using a bioelectrical impedance analysis.
Timepoint [4] 287533 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.
Secondary outcome [5] 287534 0
Acceptance for hazelnuts. This will be determined by using a 150mm visual analogue scale.
Timepoint [5] 287534 0
At baseline, weeks 4, 6 and 10 after the intervention commencement.

Eligibility
Key inclusion criteria
The inclusion criteria are Maori and European males and females aged between 18 and 65 years of age. They should be in good health.
Minimum age
18 Years
Maximum age
65 Years
Gender
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used. This will be achieved through allocation being performed by the statistician who will have no involvement in the enrolment process and is located in another building. Once participants have been accepted into the study, sufficient details for allocation (study number, age, sex, BMI) will be sent to the statistician who will return group allocation codes once blocks are complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated using random sequences of the two groups generated using SAS 9.1.3. Due to the strong possibility of age, sex, and BMI effects, groups will be balanced using 7 strata constructed using sex (M/F), age (18-40, 41-65), and BMI (25-29.9, >29.9), ethnicity (Maori/ European) categories. Allocation will be conducted by the "off-site" statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 3776 0
New Zealand
State/province [1] 3776 0
Otago

Funding & Sponsors
Funding source category [1] 269626 0
University
Name [1] 269626 0
University of Otago
Address [1] 269626 0
Department of Human Nutrition, University of Otago, Po Box 56 Dunedin, Otago, 9054
Country [1] 269626 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition, University of Otago, Po Box 56 Dunedin, Otago, 9054
Country
New Zealand
Secondary sponsor category [1] 266656 0
None
Name [1] 266656 0
Address [1] 266656 0
Country [1] 266656 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269573 0
Universtiy of Otago Ethics Committee
Ethics committee address [1] 269573 0
Ethics Committee, University of Otago, Po Box 56 Dunedin, Otago, 9054
Ethics committee country [1] 269573 0
New Zealand
Date submitted for ethics approval [1] 269573 0
08/08/2011
Approval date [1] 269573 0
Ethics approval number [1] 269573 0

Summary
Brief summary
Despite the public health recommendation to consume 30g of nuts per day, there is limited data investigating whether the recommended amount of nuts is considered acceptable to the consumer. One study reported that consuming the recommended 30 grams per day of nuts was found to be achievable and acceptable. The study population used in this research was largely European, therefore whether the results can be extrapolated to other ethics groups e.g. Maori, is unknown.

In addition to measuring the acceptability of nuts, it is of equal importance to investigate the health properties of nuts. To date, there are five human intervention trials that have investigated the effect of hazelnut supplementation on plasma cholesterol levels. As the study population in the previous studies was largely European, it is of interest to compare the health effects of regular nut consumption in European and other ethnic group, i.e. Maori.

The main aim of The Nuts2 Study is to examine the effect of regularly eating 30 grams of raw or lightly roasted/salted hazelnuts on cardiovascular disease risk factors including blood cholesterol (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, apolipoproteins) and consumers’ acceptability. The effects of hazelnut consumption on biomarkers (alpha-tocopherol, Hs-CRP, glucose, body composition and blood pressure) of heart disease will also be examined. The secondary aim of this study is to compare the acceptability and health effects of regular nut consumption between Maori and European reflective of the general population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32993 0
Address 32993 0
Country 32993 0
Phone 32993 0
Fax 32993 0
Email 32993 0
Contact person for public queries
Name 16240 0
Dr Alexandra Chisholm
Address 16240 0
Department of Human Nutrition, University of Otago, Po Box 56, Dunedin, 9054
Country 16240 0
New Zealand
Phone 16240 0
+64 3 4797514
Fax 16240 0
+64 3 4797958
Email 16240 0
alex.chisholm@otago.ac.nz
Contact person for scientific queries
Name 7168 0
Dr Alexandra Chisholm
Address 7168 0
Department of Human Nutrition, University of Otago, Po Box 56, Dunedin, 9054
Country 7168 0
New Zealand
Phone 7168 0
+64 3 4797514
Fax 7168 0
+64 3 4797958
Email 7168 0
alex.chisholm@otago.ac.nz

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