Trial DesignThe AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial): A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol
Section snippets
Background
Cardiovascular disease (CVD) is a major cause of disease burden and death in the Australian population1 and represents a global health care crisis. Modifiable risk factors account for more than 90% of the population-attributable risk for acute myocardial ischemia worldwide,2 and with the exception of smoking, most of these factors are directly related to food habits. Despite recent efforts to target diet in primary prevention of CVD, these have not been paralleled in secondary or tertiary
Design
The AUSMED Heart Trial (Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12616000156482) is a 6-month randomized, controlled, single-blind dietary intervention in a high-risk patient group who have experienced an AMI. The primary end point will be the difference in secondary cardiovascular event rates at 1 year, between the Mediterranean diet and low-fat diet participants. By following up participants until 12 months, 6 months after the dietary intervention and staple
Dietary intake
Dietary intake will be measured for each participant using 7-day food diaries and a pilot-validated Cardio-Med Questionnaire including a 115-item food frequency questionnaire (FFQ) purpose built by the investigators to capture adherence to the principles of a Mediterranean diet in a multiethnic cohort (Kucianski et al., unpublished). Data from food diaries and FFQs will be validated by the APD and analyzed using a standard nutrient analysis program (FoodWorks™ ver 8.0; Xyris Software, Brisbane,
Discussion
The Mediterranean diet was first described as cardioprotective in the 1960s, yet dietary prevention and management strategies have largely focused on reduction of saturated fat and dietary cholesterol for the past 50 years, including in Australia.33 This focus on dietary fat may have inadvertently increased intakes of highly processed carbohydrates, contributing further to the obesity and diabetes epidemics worldwide, which in turn lead to increased CVD morbidity and mortality. There is now a
Acknowledgments
We thank La Trobe University (Understanding Disease RFA Start-Up Grant, 2014; La Trobe University DVCR support grant, 2018) and the ongoing support of our industry partners (Boundary Bend P/L [Cobram Estate EVOO], the Almond Board of Australia, Jalna Dairy Foods, Simplot Australia, Carman's, and Heinz) for supply of key foods to be provided to participants of this trial. The authors also wish to thank several contributing staff: Dr Wolf Marx (protocol updates and revisions to ethics), PhD
Author contributions
Itsiopoulos C. is the chief investigator of the study and has primary responsibility for the final content. Itsiopoulos C., Thomas C.J., Mayr H.L., and Kucianski T. wrote the article. All authors had a significant input into the design of the protocol. All authors read and approved the final manuscript. The authors declare that there is no conflict of interest.
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2022, Human Nutrition and MetabolismCitation Excerpt :Percent of agreement among reviewers was 85% with moderate agreement for full-text screening (Cohen's k of 0.456). It should be noted that a trial protocol [30] was included in the search results but not the trial pilot [29]. However, due to preliminary research on relevant systematic reviews, the trial pilot [29] was of known inclusion before the search was conducted.
Perspective: Striking a Balance between Planetary and Human Health-Is There a Path Forward?
2022, Advances in NutritionDietary measures among patients with coronary heart disease in Europe. ESC EORP Euroaspire V
2020, International Journal of CardiologyCitation Excerpt :Although there is little evidence from randomized control trials that a healthy diet improves morbidity and mortality after a CHD event [23], guidelines regarding dietary management of CHD patients have been issued based on available prospective data [4–7] or on randomized trials including diet [24]. Importantly, several ongoing randomized controlled trials assessing the impact of diet on secondary prevention will provide the long-awaited information regarding the type of diet to recommend to CHD patients [25–27]. In ESC EORP Euroaspire V, dietary advice was provided to two-thirds of CHD patients, and the type of advice provided was relatively constant, including the reduction (in descending order)of fat, salt, sugar and calories, and the increase (in descending order) of fruits & vegetables, fish, oily fish and foods enriched with plant stanols/sterols.
Mediterranean diet and its components
2020, Nutraceuticals in Brain Health and BeyondAd libitum Mediterranean diet reduces subcutaneous but not visceral fat in patients with coronary heart disease: A randomised controlled pilot study
2019, Clinical Nutrition ESPENCitation Excerpt :Results from this pilot will be used to inform feasibility and sample size requirements for future analyses. The data reported in this study was collected in the pilot of the AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial), a multi-centre, parallel design, randomised controlled trial (RCT) of 6-month MedDiet versus low-fat diet intervention for the secondary prevention of CHD at 12-months in a multi-ethnic Australian population (Australia and New Zealand Clinical Trials Register: ACTRN12616000156482) [30]. As noted above, this pilot study and methodology, including results for nutritional intake and diet quality [29], the dietary inflammatory index, hs-CRP and hs-IL-6 [28,31] has previously been reported.
Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12616000156482.