Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000178448
Ethics application status
Approved
Date submitted
19/03/2007
Date registered
21/03/2007
Date last updated
21/03/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Fatty acids, Lipids And Sensory properties of Hazelnuts [The FLASH Study]
Scientific title
A randomised, controlled dietary intervention to assess the effects of incorporating hazelnuts in three different forms (ground, sliced, whole) into the usual diet, on lipid and lipoprotein mediated risk factors for cardiovascular disease (CVD) in hypercholesterolemic subjects.
Universal Trial Number (UTN)
Trial acronym
FLASH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects with elevated cholesterol level (above 4.8 mmol/L) 1696 0
Condition category
Condition code
Diet and Nutrition 1788 1788 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be asked to consume 30g of three different forms (ground, sliced, whole) of hazelnuts each day for twelve weeks. For the first two weeks of the study, the participants will consume their normal diet (Baseline). After this two-week period, they will be randomly allocated to receive one form of the hazelnut for a four-week-period. This will be followed by a two-week washout period where they will not consume any study hazelnut or other nuts. They will then be allocated to receive a second form of hazelnut for four weeks. This again is followed by a two-week washout period. Lastly, they will receive the third form of hazelnut for a period of four weeks. The study lasts 18 weeks in total.
Intervention code [1] 1655 0
Lifestyle
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 2502 0
Cholesterol
Timepoint [1] 2502 0
At 4, 6, 10, 12 and 16 weeks after intervention commencement
Primary outcome [2] 2503 0
Lipoprotein
Timepoint [2] 2503 0
At 4, 6, 10, 12 and 16 weeks after intervention commencement
Secondary outcome [1] 4317 0
Antioxidant capacity
Timepoint [1] 4317 0
At baseline and at 4, 6, 10, 12 and 16 weeks after intervention commencement.

Eligibility
Key inclusion criteria
• Healthy • Blood cholesterol > 4.8 mmol/L
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People who are taking cholesterol-lowering medication or medication known to affect blood lipid levels• Presence of familial or secondary hyperlipidaemia or major chronic illness• People who have asthma• People who have food allergies • Body Mass Index (BMI) > 30 [weight (kg) / height (m)2].

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be sequentially allocated on basis of entry into study. The six possibilities for sequence for the three treatments will be randomly generated by a researcher who is not involved in the study in any other way.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to treatment groups without stratification, using permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 491 0
New Zealand
State/province [1] 491 0

Funding & Sponsors
Funding source category [1] 1939 0
Charities/Societies/Foundations
Name [1] 1939 0
National Heart Foundation of New Zealand
Country [1] 1939 0
New Zealand
Primary sponsor type
Individual
Name
Dr Alex Chisholm
Address
Country
Secondary sponsor category [1] 1750 0
Individual
Name [1] 1750 0
Dr Rachel Brown
Address [1] 1750 0
Country [1] 1750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3617 0
University of Otago
Ethics committee address [1] 3617 0
Ethics committee country [1] 3617 0
New Zealand
Date submitted for ethics approval [1] 3617 0
Approval date [1] 3617 0
29/09/2006
Ethics approval number [1] 3617 0
06/142

Summary
Brief summary
Diets high in nuts with favourable fatty acid profiles and other bioactive substances such as phytochemicals can lower plasma cholesterol, and thus reduce the risk of CVD. Epidemiologic studies have consistently demonstrated an inverse association between nut consumption and CVD in different population groups. Numerous clinical studies have shown the cholesterol-lowering effects of several nuts, such as almonds, macademia nuts, peanuts, pecans, walnuts and various nuts. To date, there are only two human intervention trials that have investigated the effect of hazelnut supplementation on plasma cholesterol levels.

Furthermore, the physical form in which the nuts are consumed may be important. One study has suggested that the cell walls of intact almond seeds hinder the release of lipid available for digestion, which could lead to a reduction in lipid bio-availability. It is possible that the different forms of nuts may differ in lipid bio-availability and total antioxidant capacity, and thus, have differing effects on lipid and lipoprotein mediated risk factors for CVD. Therefore, the aim of the FLASH study is to investigate the effects of incorporating three different forms (ground, sliced, whole) of hazelnuts into the usual diet on plasma lipids using a randomized, multiple crossover design.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27758 0
Address 27758 0
Country 27758 0
Phone 27758 0
Fax 27758 0
Email 27758 0
Contact person for public queries
Name 10844 0
Dr Alex Chisholm, Dr Rachel Brown
Address 10844 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 10844 0
New Zealand
Phone 10844 0
+64 3 479 7514, +64 3 479 5839
Fax 10844 0
+64 3 479 7949
Email 10844 0
[email protected], [email protected]
Contact person for scientific queries
Name 1772 0
Dr Alex Chisholm, Dr Rachel Brown
Address 1772 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 1772 0
New Zealand
Phone 1772 0
+64 3 479 7514, +64 3 479 5839
Fax 1772 0
+64 3 479 7949
Email 1772 0
[email protected], [email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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