Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000337572
Ethics application status
Approved
Date submitted
28/07/2006
Date registered
8/08/2006
Date last updated
7/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
To compare the effect of meals rich in saturated fat, canola oil and bran on postprandial levels of pro-inflammatory cytokines and interleukin-8 in obese and non-obese subjects
Scientific title
To compare the effect of meals rich in saturated fat, canola oil and bran on postprandial levels of pro-inflammatory cytokines and interleukin-8 in obese and non-obese subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese subjects 1309 0
Non-obese otherwise healthy subjects 1310 0
Condition category
Condition code
Diet and Nutrition 1397 1397 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administered 5 meals. Meal A, dehydrated potato (40 g); Meal B, dehydrated potato (40 g) plus saturated fat (1.6 g cream/kg body weight); Meal C, dehydrated potato (40 g) plus canola oil (0.6 g/kg body weight), Meal D, dehydrated potato (40 g) plus olive oil (0.6 g/kg body weight); Meal E, wheat bran (44 g) plus 40 ml trim milk. The meals all contained 2 cooked eggs. The potato was hydrated by addition of hot water. The meals were administered to an individual at the rate of one per week for 5 weeks. The subjects consumed the meals in the early morning (0800-0830 h). The total study period for an individual was 5 weeks.
Intervention code [1] 1216 0
Other interventions
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1906 0
Change in plasma interleukin-6 during the postprandial period after the meals.
Timepoint [1] 1906 0
Measured at baseline and 1 h, 4 h, and 6 h after the meals.
Primary outcome [2] 1907 0
Change in tumor necrosis factor-alpha during the postprandial period after the meals.
Timepoint [2] 1907 0
Measured at baseline and 1 h, 4 h, and 6 h after the meals.
Primary outcome [3] 1908 0
Change in C-reactive protein during the postprandial period after the meals.
Timepoint [3] 1908 0
Measured at baseline and 1 h, 4 h, and 6 h after the meals.
Primary outcome [4] 1909 0
Change in interleukin-8 during the postprandial period after the meals.
Timepoint [4] 1909 0
Measured at baseline and 1 h, 4 h, and 6 h after the meals.
Primary outcome [5] 1910 0
Change in peroxides during the postprandial period after the meals.
Timepoint [5] 1910 0
Measured at baseline and 1 h, 4 h, and 6 h after the meals.
Secondary outcome [1] 3368 0
Postprandial changes in plasma insulin, glucose, free fatty acids, and lipids.
Timepoint [1] 3368 0
The outcomes were be measured at baseline and 1 h, 4 h and 6 h after the meals.

Eligibility
Key inclusion criteria
BMI >=30 kg/m2 and waist circumference >=90 cm for men and >= 88 cm in women. BMI =20-25 kg/m2 and waist circumference < 90 cm for men and <88 cm for women.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cigarette smoking; history of cardiovascular disease; chronic infections; serious illnesses; use of medications including hormone replacement therapy. Women using the contraceptive pill and subjects with features of the metabolic syndrome including hypertension and dyslipidaemia will not be excluded.

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)
Allocation schedule held by independent person who was contacted verbally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Used Mutually Orthogonal Latin Squares Randomisation on www.ams.org/new-in-math/cover/latinII3.html web site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Comparison of 5 different meals
Phase
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 382 0
New Zealand
State/province [1] 382 0

Funding & Sponsors
Funding source category [1] 1531 0
Charities/Societies/Foundations
Name [1] 1531 0
National Heart Foundation of New Zealand
Country [1] 1531 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 1345 0
Charities/Societies/Foundations
Name [1] 1345 0
Endocrinology Research Fund
Address [1] 1345 0
Country [1] 1345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2954 0
Lower South Regional Ethics Committee-Dunedin Hospital
Ethics committee address [1] 2954 0
Medicine Section 9th Floor, Dunedin Hospital Dunedin
Ethics committee country [1] 2954 0
New Zealand
Date submitted for ethics approval [1] 2954 0
Approval date [1] 2954 0
Ethics approval number [1] 2954 0
02/05/047

Summary
Brief summary
Meals rich in saturated fat increase postprandial levels of pro-inflammatory cytokines in subjects with type 2 diabetes and to a lesser degree in healthy subjects. In the present study we aimed to compare the effect of meals rich in saturated fat and monounsaturated fat and meals rich in bran and potato on pro-inflammatory cytokines and interleukin-8 in obese and nonobese subjects. Frequent acute increases in levels of pro-inflammatory cytokines as a result of regularly eating meals rich in saturated fat may increase the risk of developing diabetes particularly in obese subjects. The principal investigators, data analyst and laboratory staff were blinded to the meal allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35250 0
Address 35250 0
Country 35250 0
Phone 35250 0
Fax 35250 0
Email 35250 0
Contact person for public queries
Name 10405 0
Dr Wayne HF Sutherland
Address 10405 0
Department of Medical and Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 10405 0
New Zealand
Phone 10405 0
+64 3 4740999 ext. 8512
Fax 10405 0
+64 3 4747641
Email 10405 0
[email protected]
Contact person for scientific queries
Name 1333 0
Dr Wayne HF Sutherland
Address 1333 0
Department of Medical and Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 1333 0
New Zealand
Phone 1333 0
+64 3 4740999 ext. 8512
Fax 1333 0
+64 3 4747641
Email 1333 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
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