Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000285055
Ethics application status
Approved
Date submitted
8/04/2010
Date registered
9/04/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Nuts for LIFE (Lipids, InFlammation, Endothelial) Study: The dose-response effect of hazelnut consumption on blood lipids, inflammatory markers and endothelial function in overweight and obese individuals
Scientific title
A 12-week randomised, parallel dietary intervention to compare the effects of consuming 30g or 60g of nuts per day, or no nuts (control) on biomarkers of chronic disease, including blood lipids, inflammation, endothelial function, and body composition in overweight and obese individuals.
Secondary ID [1] 1579 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight / Obesity 257102 0
Condition category
Condition code
Diet and Nutrition 257257 257257 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, controlled, parallel intervention trial with three arms: no nuts (control group), 30g of hazelnuts per day, 60g of hazelnuts per day. The study will be carried out to assess the effects of incorporating hazelnuts at two different doses (30 g/d, 60 g/d) with a diet without nuts on blood lipids and lipoproteins, inflammatory markers, endothelial function, body composition and oral fatty acid sensitivity in overweight and obese people. A 2-week run-in period will be used to control for baseline effects of nut intake, in which all participants will be asked to minimise nut intake and keep a nut diary. Baseline measurements will be collected from each participant after the run-in period. After collecting all the baseline measurements, each participant will be randomly allocated to one of the three groups for a period of 12 weeks.
Intervention code [1] 256269 0
Lifestyle
Comparator / control treatment
Control group - No treatment. The control group will receive no additional food during the intervention.
Control group
Active

Outcomes
Primary outcome [1] 258162 0
Inflammatory markers. Plasma high-sensitivity C-reactive protein (Hs-CRP) will be measured by using a Cobas Mira Plus Analyser. Plasma intracellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-alpha) will be measured by using Quantikine enzyme-linked immunosorbent assay (ELISA) Kits.
Timepoint [1] 258162 0
At baseline and at 6 and 12 weeks after intervention commencement
Primary outcome [2] 258163 0
Endothelial function. This will be measured by using a SphygmoCor system.
Timepoint [2] 258163 0
At baseline and at 12 weeks after intervention commencement
Primary outcome [3] 258164 0
Plasma lipids and lipoproteins. Plasma total cholesterol, high density lipoprotein cholesterol (HDL-C) and triglyceride concentrations will be measured by enzymatic methods using a Cobas Mira Plus analyser. Plasma low density lipoprotein cholesterol (LDL-C) concentration will be calculated using the Friedewald formula.
Timepoint [3] 258164 0
At baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [1] 263805 0
Body composition. This will be measured by using a bioelectrical impedance analysis.
Timepoint [1] 263805 0
At baseline and at 6 and 12 weeks after intervention commencement
Secondary outcome [2] 263806 0
Oral fatty acid sensitivity. This will be determined via triplicate sensory evaluations (triangle tests).
Timepoint [2] 263806 0
At baseline and at 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria are males and females aged between 18 and 65 years with a Body Mass Index (BMI) greater than or equal to 25 [weight (kg) / height (m2)]
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are smokers. Pregnant or breastfeeding women. People who have asthma. People who are on weight loss programmes. People with food allergies or food aversions to nuts. People who have inflammatory diseases such as Crohn's or Celiac disease. 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 inflammatory markers, e.g. aspirin, ibuprofen, naproxen, glucocorticoids, etc.

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 enrollment 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 three groups generated using SAS 9.1.3. Due to the strong possibility of age, sex, and BMI effects, groups will be balanced using 8 strata constructed using sex (M/F), age (18-40, 41-65), and BMI (25-29.9, >29.9) categories. Allocation will be conducted by the "off-site" statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
8/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2571 0
New Zealand
State/province [1] 2571 0
Otago

Funding & Sponsors
Funding source category [1] 256771 0
Charities/Societies/Foundations
Name [1] 256771 0
National Heart Foundation of New Zealand
Country [1] 256771 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] 256050 0
None
Name [1] 256050 0
Address [1] 256050 0
Country [1] 256050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258793 0
University of Otago Ethics Committee
Ethics committee address [1] 258793 0
Ethics committee country [1] 258793 0
New Zealand
Date submitted for ethics approval [1] 258793 0
Approval date [1] 258793 0
23/03/2010
Ethics approval number [1] 258793 0
Reference Number 10/051

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

Contacts
Principal investigator
Name 31025 0
Address 31025 0
Country 31025 0
Phone 31025 0
Fax 31025 0
Email 31025 0
Contact person for public queries
Name 14272 0
Dr Rachel Brown
Address 14272 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 14272 0
New Zealand
Phone 14272 0
+64 3 4795839
Fax 14272 0
+64 3 4797958
Email 14272 0
[email protected]
Contact person for scientific queries
Name 5200 0
Dr Rachel Brown
Address 5200 0
Department of Human Nutrition, University of Otago, PO Box 56, Dunedin 9054
Country 5200 0
New Zealand
Phone 5200 0
+64 3 4795839
Fax 5200 0
+64 3 4797958
Email 5200 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.