Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000156482
Ethics application status
Approved
Date submitted
12/01/2016
Date registered
10/02/2016
Date last updated
23/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The AUSMED Heart Trial: The Australian Mediterranean diet trial for secondary prevention of heart disease
Scientific title
The effects of a Mediterranean dietary intervention in modifying cardiovascular risk factors in high-risk individuals who have experienced a cardiac event.
Secondary ID [1] 288286 0
None
Universal Trial Number (UTN)
Trial acronym
AUSMED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 297247 0
Cardiovascular Disease 297248 0
Type 2 Diabetes 297249 0
Condition category
Condition code
Diet and Nutrition 297451 297451 0 0
Other diet and nutrition disorders
Cardiovascular 297452 297452 0 0
Coronary heart disease
Metabolic and Endocrine 297453 297453 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mediterranean diet versus standard diet.
Patients are randomised to either the Mediterranean diet intervention arm or the standard diet (low fat, National Heart Foundation guidelines, Australian Guide to Healthy Eating) control arm. Participants of both study arms will receive individualised counselling from an Accredited Practicing Dietitian (APD) across a 6 month period and then a phone call follow up at 12 months. The consults with an APD will be face-to-face at baseline, mid-intervention (3 months) and end of intervention (6 months). For these appointments diet adherence will be assessed through food diaries and food frequency questionnaire, blood/urine samples taken, activity levels monitored via accelerometer and anthropometric measures and DEXA scans performed. Each face-to-face appoint will take approximately 1.5 to 2 hours. Review phone calls (approximately 15 minutes each) will also be conducted every 3 weeks up until the 3 month review appointment and on a monthly basis up until counselling cessation at 6 months. A final follow up phone call of approximately 20 minutes duration will be conducted at 12 months to assess feasibility of sustaining the diet. Meal plans and recipes relevant to the diet group are provided at baseline. The Mediterranean diet intervention is prescribed ad libitum and composed of a high fat (approximately 40% of total energy intake), moderate carbohydrate and moderate protein intake. Key foods promoted are extra virgin olive oil, nuts, legumes, wholegrains, fruits, vegetables, seafood, fermented dairy products, herbs and spices, with limited intake of red meat. To achieve dietary goals, the intervention group are provided with a food hamper representing typical Mediterranean diet foods (olive oil, nuts, natural Greek yoghurt, tinned fish and legumes) and the control standard diet group are provided a supermarket voucher to purchase low fat/recommended healthy food products. These will be provided at baseline and 3 month appointments.
Intervention code [1] 293578 0
Lifestyle
Intervention code [2] 293579 0
Treatment: Other
Comparator / control treatment
The standard diet for the control arm is modelled on the National Heart Foundation guidelines for a low fat/moderate carbohydrate diet and the Australian Guide to Healthy Eating recommendations. The control standard diet is prescribed ad libitum and targets a fat intake of less than 30% of total energy with a focus on a reduction in saturated fat (<7% total energy intake) and salt. Polyunsaturated, particularly Omega-3, fats are encouraged as per the National Heart Foundation recommendations. Food group recommendations are based on the Australian Guide to Healthy Eating recommended daily serves. The control group will receive the same level of attention and dietary counselling as the Mediterranean diet intervention group.
Control group
Active

Outcomes
Primary outcome [1] 297012 0
Cardiac endpoints (Acute Myocardial Infarction, Coronary Artery Bypass Surgery, Angioplasty, cardiovascular mortality, all-cause mortality) measured via self-report, hospital medical records and death registry.
Timepoint [1] 297012 0
Across 12 months from the beginning of the intervention.
Secondary outcome [1] 319840 0
Blood lipid/metabolic profile - assessing fasting total cholesterol, LDL, HDL, Triglycerides and glucose from serum levels in blood.
Timepoint [1] 319840 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [2] 319841 0
Inflammatory cytokine markers, including a composite of high sensitivity C-Reactive Protein and Interleukin-6, using serum blood analysis.
Timepoint [2] 319841 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [3] 319842 0
Coagulation factors (Fibrinogen, Antithrombin III, factor VII, factor VIII, Plasminogen activator inhibitor-1) using plasma blood analysis
Timepoint [3] 319842 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [4] 319843 0
Dietary adherence to Mediterranean diet versus low fat/moderate carbohydrate interventions will be measured via self-reported 7-day food diaries, tailored cardiology food frequency questionnaire and validated 14-item Mediterranean diet adherence score (PREDIMED study) as well as objective measures of compliance including plasma carotenoids, plasma fatty acids and urinary hydroxytyrosol..
Timepoint [4] 319843 0
Baseline, 3 months and 6 months across the dietary intervention period. Sustainability of dietary adherence will also be assessed at the 12 month phone call follow up via food frequency questionnaire and 14-item Mediterranean diet adherence PREDIMED score.
Secondary outcome [5] 319844 0
Body composition ass measured by DEXA scan to assess changes in fat and lean muscle mass.
Timepoint [5] 319844 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [6] 319845 0
Anthropometric measures as a composite of body mass index, incorporating weight (calibrated stand-on scales) and height, and waist, hip, neck circumferences.
Timepoint [6] 319845 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [7] 319846 0
Blood pressure will be measured using sphygmomanometer.
Timepoint [7] 319846 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [8] 319848 0
Activity levels measured via triaxial Actigraph accelerometers, worn across a 7-day continuous period.
Timepoint [8] 319848 0
During the week prior to the baseline, 3 months and 6 month appointments of the diet intervention period.
Secondary outcome [9] 319849 0
Quality of Life measure via SF 36 Questionnaire.
Timepoint [9] 319849 0
Baseline, 3 months and 6 months across the diet intervention period.
Secondary outcome [10] 319950 0
Adipokine markers, including a composite of Adiponectin (anti-inflammatory) and Resitin (inflammatory), using serum blood analysis.
Timepoint [10] 319950 0
Baseline, 3 month and 6 month appointments across the diet intervention.
Secondary outcome [11] 319951 0
Adhesion molecule markers of endothelial function, including soluble intracellular adhesion molecule-1and Vascular cell adhesion molecule-1, using serum blood analysis.
Timepoint [11] 319951 0
Baseline, 3 month and 6 month appointments across the diet intervention.

Eligibility
Key inclusion criteria
Eligible participants will be high risk cardiology patients who have experienced a cardiac event with acute presentation to The Northern Hospital or St Vincent's Hospital. Cardiac event includes participants who have suffered an acute myocardial infarction (AMI) (stemi or non-stemi infarct), angina pectoris or have had coronary artery bypass surgery (CABG), balloon angioplasty (with or without stent). Participants will also be included if they have type 2 diabetes or metabolic syndrome.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes participants that: are non-English speaking, have active malignancy, chronic heart failure, chronic inflammatory disease (e.g. Inflammatory bowel disease, Rheumatoid arthritis, renal failure or on dialysis, liver disease), Body mass index (BMI) >40kg/m2, are currently breastfeeding or pregnant, currently participating in an intervention targeting diet or exercise, inability to attend the counselling sessions or examinations, inability to complete the six month dietary intervention due to medical, cultural, social, religious factors or food allergies/intolerances that prevent them from consuming the intervention foods.

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 who consent to participate in the study will be randomised (using a computer generated stratified approach generated by a statistician) into the Mediterranean diet intervention group or the standard diet control group. The person determining the subjects eligibility was not involved in the computer generation of stratification and randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on gender, age and prior acute presentation of myocardial infarction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is assumed that at the end of the 12-month follow-up, 93% of subjects in the Mediterranean diet treatment arm will not experience a cardiac event and 86% of subjects in the control standard diet arm will also not experience an event. The assumption that the intervention can reduce the event rates by 7% is conservative compared to the observed event rate difference of 11% in the Lyon Heart Study (de Lorgeril et al., 1999). To detect this 7% difference in event rates between the two groups with at least 80% power, 305 subjects per arm need to be recruited (95% significance level is assumed). The aim to recruit 340 subjects per arm (680 subjects in total) allows for a 10% drop out rate.
Continuous data will be expressed as mean +/-SD. Fisher’s exact tests will be used to evaluate categorical measures. Continuous variables recorded at baseline will be analysed using the Student’s t-tests. All analyses will be conducted with intention to treat. For intermediate outcomes measured, they will be evaluated by plotting Kaplan-Meir curves. Odds ratios will be calculated with multivariate Cox proportional-hazards models. For continuous measures (risk factors and food diary data) recorded longitudinally at 3 and 6 months, multilevel random-effects modelling will be used. Two-tailed p values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
680
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5017 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 5018 0
The Northern Hospital - Epping

Funding & Sponsors
Funding source category [1] 292664 0
University
Name [1] 292664 0
La Trobe University
Country [1] 292664 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Discipline of Dietetics and Human Nutrition
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 291381 0
None
Name [1] 291381 0
Address [1] 291381 0
Country [1] 291381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294133 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 294133 0
Ethics committee country [1] 294133 0
Australia
Date submitted for ethics approval [1] 294133 0
05/07/2013
Approval date [1] 294133 0
11/07/2013
Ethics approval number [1] 294133 0
FHEC13/159
Ethics committee name [2] 294134 0
The St Vincent's Hospital (Melbourne) Human Research Ethics Committee-A
Ethics committee address [2] 294134 0
Ethics committee country [2] 294134 0
Date submitted for ethics approval [2] 294134 0
20/02/2013
Approval date [2] 294134 0
03/07/2013
Ethics approval number [2] 294134 0
HREC-A 016/13
Ethics committee name [3] 294136 0
Austin Health Human Research and Ethics Committee
Ethics committee address [3] 294136 0
Ethics committee country [3] 294136 0
Australia
Date submitted for ethics approval [3] 294136 0
01/04/2013
Approval date [3] 294136 0
07/05/2013
Ethics approval number [3] 294136 0
HREC/16/Austin/500

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62642 0
Prof Catherine Itsiopoulos
Address 62642 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora VIC 3086
Country 62642 0
Australia
Phone 62642 0
+61 (0) 3 9479 1721
Fax 62642 0
+61 (0) 3 9479 2507
Email 62642 0
[email protected]
Contact person for public queries
Name 62643 0
Catherine Itsiopoulos
Address 62643 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora VIC 3086
Country 62643 0
Australia
Phone 62643 0
+61 (0) 3 9479 1721
Fax 62643 0
+61 (0) 3 9479 2507
Email 62643 0
[email protected]
Contact person for scientific queries
Name 62644 0
Catherine Itsiopoulos
Address 62644 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora VIC 3086
Country 62644 0
Australia
Phone 62644 0
+61 (0) 3 9479 1721
Fax 62644 0
+61 (0) 3 9479 2507
Email 62644 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImprovement in dietary inflammatory index score after 6-month dietary intervention is associated with reduction in interleukin-6 in patients with coronary heart disease: The AUSMED heart trial.2018https://dx.doi.org/10.1016/j.nutres.2018.04.007
EmbaseRandomization to 6-month Mediterranean diet compared with a low-fat diet leads to improvement in Dietary Inflammatory Index scores in patients with coronary heart disease: the AUSMED Heart Trial.2018https://dx.doi.org/10.1016/j.nutres.2018.04.006
EmbaseThe 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.2018https://dx.doi.org/10.1016/j.ahj.2018.05.010
N.B. These documents automatically identified may not have been verified by the study sponsor.