Table 1 World Health Organisation Trial Registration Data Set
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 (45-80Â years) with elevated blood pressure (>120Â 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. |