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Trial registered on ANZCTR


Registration number
ACTRN12620000689976p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2020
Date registered
22/06/2020
Date last updated
22/06/2020
Date data sharing statement initially provided
22/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy carbohydrates or healthy fats following an acute coronary event?
Scientific title
Optimal carbohydrate or optimal fat intakes for cardiometabolic risk factor management in adults with coronary heart disease: randomised controlled trial
Secondary ID [1] 300869 0
None
Universal Trial Number (UTN)
U1111-1250-1499
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 316789 0
Condition category
Condition code
Cardiovascular 315005 315005 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three arm trial with interventions of twelve weeks duration. The control arm is the provision of usual care following a coronary event, including both pharmacological intervention and lifestyle advice (usual care arm). The usual care for all trial participants will be delivered by the cardiovascular outpatient clinics available to all people following an acute coronary event in New Zealand.

One active intervention is the provision of usual care and a weekly delivery of high fibre carbohydrate foods (healthy carbs arm). Tinned legumes, wholegrain foods, vegetables, and whole fruit will be delivered in sufficient amounts to feed the participant and those they live with. The purpose of the intervention is to provide sufficient quantity and choice that participants may choose from within the foods to suit their preferences.

The second active intervention is the provision of usual care and the weekly delivery of foods high in healthy fats (healthy fats arm). Foods will be delivered to participant households though online supermarket grocery orders. Vegetable oil, margarine, tinned oily fish, nuts, seeds, and avocado will be delivered in sufficient amounts to feed the participant and those they live with. The purpose of the intervention is to provide sufficient quantity and choice that participants may choose from within the foods to suit their preferences.

All participants will be required to use an online portal to enter demographic data, and attend pathology labs for body weight measurement and blood draw. Food will be delivered to the house of those participants in the intervention arms (healthy carbohydrate and healthy fats). There is minimal contact between the participants and investigators, and minimal additional contact between participants and services beyond accessing routine care, so to minimise the potential transmission of infectious diseases. Participants will have the contact details of the investigators at all times however, and be able to contact them remotely at anytime within the trial. Trial recruitment will be run out of these cardiovascular outpatient clinics in two regions of New Zealand, Otago and Southland.

Intervention adherence will be assessed with gold standard dietary assessment techniques (Food Frequency Questionnaire for habitual food intake and food diaries during the interventions) as well as more novel objective biomarkers of dietary intakes pre and post interventions.
Intervention code [1] 317193 0
Lifestyle
Comparator / control treatment
Three arm trial considering carbohydrate quality. The control arm is the provision of usual care in New Zealand following a coronary event, including both pharmacological intervention and lifestyle advice (usual care arm). Usual care is not delivered by the research team of this trial, instead it is part of what health care is provided in New Zealand. Pharmacological interventions is typically the use of a statin, and other medication if deemed necessary by the participants health care team. Lifestyle advice includes obtaining a minimal amount of physical activity per day, typically of low intensity, and advice to eat a healthy dietary pattern inline with the foods being provided in the active arms of this trial.
Control group
Active

Outcomes
Primary outcome [1] 323311 0
LDL Cholesterol (mmol/L) from plasma measured on an automated analyzer (Roche Diagnostics) after calibration with the appropriate standards.
Timepoint [1] 323311 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Primary outcome [2] 323312 0
Total cholesterol (mmol/L) from plasma measured on an automated analyzer (Roche Diagnostics) after calibration with the appropriate standards.
Timepoint [2] 323312 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [1] 381518 0
HDL cholesterol (mmol/L) from plasma measured on an automated analyzer (Roche Diagnostics) after calibration with the appropriate standards.
Timepoint [1] 381518 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [2] 381519 0
Triglycerides (mmol/L) from plasma measured on an automated analyzer (Roche Diagnostics) after calibration with the appropriate standards.
Timepoint [2] 381519 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [3] 381520 0
Glycated haemoglobin (HbA1c) from whole blood measured on an automated analyzer (Roche Diagnostics) after calibration with the appropriate standards.
Timepoint [3] 381520 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [4] 381521 0
Body weight (kg) measured independently by a health professional on a Tania weight and bio electrical impedance scale.
Timepoint [4] 381521 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [5] 381522 0
Body fat percentage measured independently by a health professional on a Tania weight and bio electrical impedance scale.
Timepoint [5] 381522 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [6] 381523 0
Blood pressure (mmHg) with automated sphygmomanometer.
Timepoint [6] 381523 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [7] 381524 0
LDL lipid fractions from plasma measured with a recognised protocol following calibration with the appropriate standards.
Timepoint [7] 381524 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [8] 381525 0
Microbiota density and distribution as measured from stool sample obtained by participants.
Timepoint [8] 381525 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [9] 382570 0
C-reactive protein from plasma measured with a recognised protocol following calibration with the appropriate standards.
Timepoint [9] 382570 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [10] 382571 0
Fasting insulin concentration from plasma measured with a recognised protocol following calibration with the appropriate standards.
Timepoint [10] 382571 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.
Secondary outcome [11] 382572 0
Cytokines (Interleukins) from plasma measured on a Bio-Plex Panel measuring 37 different inflamatory markers (Bio-Plex Pro™ Human Inflammation Panel 1) .

The compounds measured are:
APRIL / TNFSF13
BAFF / TNFSF13B
sCD30 / TNFRSF8
sCD163
Chitinase-3-like 1
gp130 / sIL-6Rß
IFN-a2
IFN-ß
IFN-?
IL-2
sIL-6Ra
IL-8
IL-10
IL-11
IL-12 (p40)
IL-12 (p70)
IL-19
IL-20
IL-22
IL-26
IL-27 (p28)
IL-28A / IFN-?2
IL-29/IFN-?1
IL-32
IL-34
IL-35
LIGHT / TNFSF14
MMP-1
MMP-2
MMP-3
Osteocalcin
Osteopontin
Pentraxin-3
sTNF-R1
sTNF-R2
TSLP
TWEAK / TNFSF12
Timepoint [11] 382572 0
Pre intervention (baseline) and when the intervention ceases at 12-weeks after commencement.

Eligibility
Key inclusion criteria
Adults who have had an acute coronary event.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NA

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 to intervention made by software within an online portal following participant eligibility check and consent to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated balanced randomisation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Using data from previous trials of similar populations, we have considered primary endpoint LDL cholesterol with an aplha of 0.05 and power of 0.80 to detect a 0.2 mmol/L greater improvement in one arm over either other arm. This power calculation indicates 80 participants per intervention group is the minimum number required.

Data will be analysed according to intention to treat. We will use a mixed model to compare the pre-post data for each outcome, as well as look for interaction effects with the measured covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22455 0
New Zealand
State/province [1] 22455 0
Otago and Southland

Funding & Sponsors
Funding source category [1] 305320 0
University
Name [1] 305320 0
Riddet Institute, Massey University
Address [1] 305320 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country [1] 305320 0
New Zealand
Primary sponsor type
Individual
Name
Dr Andrew Reynolds
Address
Department of Medicine
PO Box 56
Dunedin Otago 9012
Country
New Zealand
Secondary sponsor category [1] 305692 0
None
Name [1] 305692 0
None
Address [1] 305692 0
None
Country [1] 305692 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305659 0
Health and Disability Ethics Committee - expedited pathway, to be considered by a sub-committee of HDEC members between meetings.
Ethics committee address [1] 305659 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305659 0
New Zealand
Date submitted for ethics approval [1] 305659 0
02/06/2020
Approval date [1] 305659 0
Ethics approval number [1] 305659 0

Summary
Brief summary
There is convincing evidence that a healthy balanced diet protects against future cardiovascular disease and associated comorbidities. However changing habitual dietary patterns towards a healthier choices can be hard for many, especially without additional support.

We have looked at the usual care provided in New Zealand following an acute coronary event. This includes pharmacological interventions and lifestyle advice, such as adoption of a healthy diet. We are interested to see if the provision of certain foods increases adherence to a healthy diet, and improves cardiometabolic risk factors beyond the benefits obtained from usual care. We will be testing two active interventions and comparing them against the results achieved through usual care. One intervention is the provision of high fibre carbohydrates such as tinned legumes, wholegrain foods, vegetables, and fruit. The other intervention is the provision of foods high in healthy fats (vegetable oil, margarine, tinned oily fish, nuts, seeds, and avocado).

Interventions will be over 12 weeks, with each participant randomised to one of the three trial arms for that time. We will assess cardiometabolic risk factors at the start and at the end of each intervention. Our hypothesis is that usual care and the provision of foods inline with a healthy diet following an acute cardiovascular event improves cardiometabolic risk factors to a greater extent than what is obtained by current usual care alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101122 0
Dr Andrew Reynolds
Address 101122 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago 9012
Country 101122 0
New Zealand
Phone 101122 0
+64279565826
Fax 101122 0
Email 101122 0
andrew.reynolds@otago.ac.nz
Contact person for public queries
Name 101123 0
Dr Andrew Reynolds
Address 101123 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago 9012
Country 101123 0
New Zealand
Phone 101123 0
+64279565826
Fax 101123 0
Email 101123 0
andrew.reynolds@otago.ac.nz
Contact person for scientific queries
Name 101124 0
Dr Andrew Reynolds
Address 101124 0
Department of Medicine
University of Otago
PO Box 56
Dunedin Otago 9012
Country 101124 0
New Zealand
Phone 101124 0
+64279565826
Fax 101124 0
Email 101124 0
andrew.reynolds@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7453 0
Ethical approval
Citation [1] 7453 0
Link [1] 7453 0
Email [1] 7453 0
Other [1] 7453 0
Will be made available once obtained.
Attachment [1] 7453 0
Summary results
No Results