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Trial registered on ANZCTR


Registration number
ACTRN12621000743864
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Effect of Plant Based Diets on Cardiovascular Disease Risk
Scientific title
Investigating the risk of cardiovascular disease in middle-aged Australians who follow plant-based dietary patterns or omnivorous diet patterns (regular meat eaters).
Secondary ID [1] 303563 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease (CVD) 320927 0
Condition category
Condition code
Cardiovascular 318735 318735 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligible participants will be required to attend a total of 2 appointments. Participants will attend one appointment at the Newcastle Bone Density (NBD) Centre which is a private medical imaging center in Newcastle. Weight, height, body composition and BMI will be measured via dual-energy x-ray absorptiometry (DXA) using the GE Lunar Prodigy DXA machine (narrow angle fan beam technology) by a consulting radiation expert. Participants will attend the center, at least 3 days prior to their clinic appointment at the University of Newcastle. All participants will be required to complete a DXA Screening Questionnaire and written consent. Participants will be asked to wear light pull on clothing that is not bulky, avoid wearing any metal on their person including jewellery. Participants will then be asked to lie on a scanner bed while a scanning arm passes over the body. The DXA scan will be measured once only and it takes approximately 6 minutes to complete. Scan results and the signed DXA Screening Questionnaire will be emailed to study investigators from the technicians at the NBD Centre.

The second appointment is an 2-hour clinic appointment at the University of Newcastle after an overnight (minimum 10 hour) fast (no food or beverage, except water), refraining from alcohol consumption and vigorous physical activity 24 hours prior to the appointment. Study participation involves completing a series of questionnaires (demographic & medical history, food frequency and physical activity), an interviewer-administered diet history, collection of a fasted blood sample, blood pressure and anthropometric measurements conducted by lead investigator GA. Participants will be provided with light refreshments at the conclusion of the clinic appointment. After analysis of the food frequency questionnaire and diet history participants will be placed into the following PBD categories;

1. Semi-Vegetarian if they reported eating 1 or less that 1 time(s) per week beef, lamb or pork; 1 or less than 1 time(s) per week chicken, turkey or duck; 1 or less than 1 time(s) per week processed meat and 1 or less than 1 times(s) per week fish or seafood; with a total of equal to or less than 1 time(s) per week for the four listed categories.
2. Pesco-Vegetarian if they reported eating nil beef, lamb, pork, chicken, turkey, duck, processed meat and 1 or less than 1 times(s) per week fish or seafood.
3. Lacto-ovo Vegetarian if they reported eating nil beef, lamb, pork, chicken, turkey, duck, processed meat, fish or seafood 1 or less than 1 time(s) per week animal-derived foods such as dairy products and/or eggs.
4. Vegan if they reported excluding all animal flesh and animal-derived foods such as dairy products and eggs.
Intervention code [1] 319934 0
Diagnosis / Prognosis
Comparator / control treatment
After analysis of the food frequency questionnaire and diet history placebo/control participants will be defined as;

1. Regular Meat Eater if they reported eating 1 or more than 1 times(s) per week beef, lamb or pork; 1 or more than 1 time(s) per week chicken, turkey or duck; 1 or more than 1 time(s) per week processed meat and 1 or more than 1 time(s) per week fish or seafood; with a total of more than 1 time(s) per week for the four listed categories.
Control group
Active

Outcomes
Primary outcome [1] 326784 0
Associated risk of CVD measured by 10-year CVD risk (%) measured via the Framingham Risk Algorithm.
Timepoint [1] 326784 0
Baseline with no follow up.
Secondary outcome [1] 392667 0
Body composition (fat mass, skeletal muscle mass) measured via duel X-ray absorptiometry (DXA).
Timepoint [1] 392667 0
Baseline with no follow up.
Secondary outcome [2] 392957 0
Bone mineral content (Bone mineral density score (BMD)) measured via DXA.
Timepoint [2] 392957 0
Baseline with no follow up.
Secondary outcome [3] 392958 0
Anthropometry (weight, height, BMI, waist circumference) measured via DXA
Timepoint [3] 392958 0
Baseline with no follow up.
Secondary outcome [4] 392959 0
Blood pressure (systolic and diastolic) measured using a digital blood pressure monitor.
Timepoint [4] 392959 0
Baseline with no follow up.
Secondary outcome [5] 392960 0
Blood lipids (fasting plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and total-HDL-cholesterol ratio) measured via venipuncture blood collection.
Timepoint [5] 392960 0
Baseline with no follow up.
Secondary outcome [6] 392961 0
Glycaemia indices (fasting plasma glucose, insulin, HbA1c) measured via venipuncture blood collection.
Timepoint [6] 392961 0
Baseline with no follow up.
Secondary outcome [7] 392962 0
Full blood count measured via venipuncture blood collection.
Timepoint [7] 392962 0
Baseline with no follow up,
Secondary outcome [8] 392963 0
Liver function tests measured via venipuncture blood collections.
Timepoint [8] 392963 0
Baseline with no follow up.
Secondary outcome [9] 392964 0
Vitamin D (25-hydroxy vitamin D) measured by venipuncture blood collection.
Timepoint [9] 392964 0
Baseline with no follow up.
Secondary outcome [10] 392966 0
Dietary profile (serves from food groups) measured using FoodWorks (Xyris®) software program.
Timepoint [10] 392966 0
Baseline with no follow up.
Secondary outcome [11] 395067 0
Nutritional composition (nutrient intake) measured using FoodWorks (Xyris®) software program.
Timepoint [11] 395067 0
Baseline with no follow up

Eligibility
Key inclusion criteria
Middle-aged adults without existing cardiovascular disease
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Cardiovascular disease diagnoses and/or are being treated for cardiovascular disease
• Pregnant or lactating
• Recently commenced a dietary intervention in the past 6 months
• Made significant changes to their dietary patterns, food choices, lifestyle and/or physical activity levels in the past 6 months
• Currently participating in (or in the last 30 days) another research intervention trial involving dietary intervention and/or physical activity intervention.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Dietary pattern data from the AES will be compared against the current 2013 Australian Dietary Guidelines (qualitatively) and macronutrient and micronutrient data obtained from the AES will be compared against the Nutrient Reference Vales (NRVs) for Australia and New Zealand (quantitatively). Dietary intakes assessed from diet histories will be summarised and examined using FoodWorks (Xyris®).
All data will be assessed for normality using Shapiro Wilk test and inspecting visual plots such as histograms and box plots. All data will be presented as means±SEM or median with interquartile range (25th-75th percentile) and a significance level of 0.05 will indicate statistical significance for all tests. Analysis of variance or Kruskall Wallis will be used for comparison of dietary intake and cardiometabolic parameters including all clinical measures, blood parameters and CVD risk scores across dietary pattern groups. Frequency and contingency tables will be used for summarising qualitative dietary data (collected from the FFQ) across dietary pattern groups. Chi-square test will be used to compare qualitative dietary intake data and other categorical data across various plant-based diet groups and regular meat eaters.
Analysis of covariance will be used to investigate the effects of potential confounding factors such as age, gender and duration of dietary status. All statistical analyses will be conducted using StataCorp (Stata Statistical Release Software: Release 14. College Station, TX: StataCorp LP). Statistical support will be provided by the Hunter Medical Research Institute’s (HMRI) Statistical Support Team (Creditts) at all stages of analyses including cross-checks of analysis outputs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
Date of last participant enrolment
Anticipated
17/12/2021
Actual
Date of last data collection
Anticipated
25/02/2022
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 33385 0
2300 - Newcastle
Recruitment postcode(s) [2] 33449 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 308065 0
University
Name [1] 308065 0
University of Newcastle, Nutraceuticals Research Program
Country [1] 308065 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308895 0
None
Name [1] 308895 0
None
Address [1] 308895 0
None
Country [1] 308895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307979 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 307979 0
Ethics committee country [1] 307979 0
Australia
Date submitted for ethics approval [1] 307979 0
Approval date [1] 307979 0
29/07/2020
Ethics approval number [1] 307979 0
H-2020-0195

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

Contacts
Principal investigator
Name 109118 0
Prof Manohar Garg
Address 109118 0
University of Newcastle
Nutraceuticals Research Program
School of Biomedical Sciences & Pharmacy
University of Newcastle
University Drive
Callaghan NSW 2308
Country 109118 0
Australia
Phone 109118 0
+61249215647
Fax 109118 0
Email 109118 0
Manohar.Garg@newcastle.edu.au
Contact person for public queries
Name 109119 0
Manohar Garg
Address 109119 0
University of Newcastle
Nutraceuticals Research Program
School of Biomedical Sciences & Pharmacy
University of Newcastle
University Drive
Callaghan NSW 2308
Country 109119 0
Australia
Phone 109119 0
+61249215647
Fax 109119 0
Email 109119 0
Manohar.Garg@newcastle.edu.au
Contact person for scientific queries
Name 109120 0
Manohar Garg
Address 109120 0
Nutraceuticals Research Program
School of Biomedical Sciences & Pharmacy
University of Newcastle
University Drive
Callaghan NSW 2308
Country 109120 0
Australia
Phone 109120 0
+61249215647
Fax 109120 0
Email 109120 0
Manohar.Garg@newcastle.edu.au

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?

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
No additional documents have been identified.