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Table 1 World Health Organisation Trial Registration Data Set

From: Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular risk and cognitive function

Data category Information
Primary registry and trial identifying number Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001046493
Date of registration in primary registry 5 August, 2016
Secondary identifying numbers University of South Australia Human Ethics Committee 35,562. Pork CRC 3B-113.
Source(s) of monetary or material support Australian Pork Cooperative Research Council
Primary sponsor Dr Karen J Murphy
Secondary sponsors Alexandra T Wade, Courtney R Davis, Kathryn A Dyer, Jonathan M Hodgson, Richard J Woodman, Hannah A.D. Keage
Contact for public queries Dr Karen J Murphy
Phone: +61 8202 2097. Email: Karen.Murphy@unisa.edu.au
Postal address: University of South Australia, GPO Box 2471, Adelaide SA 5001
Contact for scientific queries Dr Karen J Murphy, Senior Research Fellow, Dietitian, Alliance for Research in Exercise, Nutrition and Activity, University of South Australia.
Phone: +61 8202 1033. Email: Karen.Murphy@unisa.edu.au
Postal address: University of South Australia, GPO Box 2471, Adelaide SA 5001
Public title Effect of a Mediterranean diet with fresh lean Australian pork on blood pressure, cardiovascular risk factors and cognition, mood and psychological wellbeing in high risk individuals
Scientific title Including pork in the Mediterranean diet for an Australian population: Protocol for a randomised controlled trial assessing cardiovascular and cognitive outcomes
Countries of recruitment Australia
Health condition(s) or problem(s) studied Risk of cardiovascular disease (CVD)
Intervention(s) Active comparator: Mediterranean diet including fresh, lean pork
Control comparator: Low-fat diet
Key inclusion and exclusion criteria Inclusion criteria: adult (45-80 years) with elevated blood pressure (>120 mmHg) with at least two other risk factors for CVD.
Exclusion criteria: antihypertensive medication, dietary intolerances that may restrict consumption of intervention diets, current CVD, type 2 diabetes mellitus, malignancy, liver, kidney, gastrointestinal or respiratory disease, current diagnosis of dementia or use of antidepressants, anxiety or neurological medications
Study type Type: Interventional
Allocation: Randomised block allocation, parallel cross-over design
Primary purpose: prevention
Date of first enrolment 15 February 2017
Target sample size 31
Recruitment status Complete
Primary outcome(s) Home measured systolic blood pressure
Key secondary outcomes Body mass index (BMI), body composition, fasting blood lipids, C-reactive protein, fasting plasma glucose, fasting serum insulin, erythrocyte fatty acids, cognitive function, psychological health and well-being, and dementia risk.