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Trial registered on ANZCTR


Registration number
ACTRN12619000973112
Ethics application status
Approved
Date submitted
11/06/2019
Date registered
9/07/2019
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a novel criteria to rank healthiness of foods and meals in healthy individuals
Scientific title
Lipemic load: Criteria for grading foods and meals based on postprandial triglyceride kinetics (GlucoTRIG) in healthy individuals
Secondary ID [1] 298458 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 313199 0
Type 2 diabetes 313200 0
Condition category
Condition code
Diet and Nutrition 311660 311660 0 0
Obesity
Metabolic and Endocrine 311773 311773 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants agreed to participate in this study will be asked to visit our clinical facilities at the University of Newcastle, Callaghan campus. They will be asked to provide a completed consent form, complete a brief medical questionnaire, a physical activity questionnaire, 24-hour food recall. The day before each appointment participants will be asked to refrain from physical activity and alcohol consumption for 24 hours, to consume a meal low in calories, the evening before the test day (low-calorie meal is based on instructions provided by the study investigators after the screening) and fast for 10 hours. Participants will have their anthropometric measurements (weight, height, body muscle mass, etc.) and blood pressure taken, followed by a donation of one venous blood sample in fasting state. Following blood collection, study investigators will serve a reference meal (Bread, wholemeal, 2 regular slices; butter (1 x 7g tub); Peanut butter, crunchy (1 x 11g tub); OAK chocolate 250 mL) by study investigators. Participants must stay at the study site for the entire duration (3.5 hours) of each session. They will then have a blood sample collected 3 hours after meal consumption. Participants will have to consume the meal within 20 minutes. Meal consumption was monitored through direct observation of the study investigator. This visit will be repeated with a washout period of 3 days between each appointment. GlucoTRIG value of the test meals will be evaluated a wash out period of 3 days between each appointment.
Test meal -1
Uncle Toby’s Oats Quick Sachets Original- 2 sachets
Raw almonds, with skin - 9 nut
Skim Milk - 200mL
Banana, fresh, Cavendish - 1 medium
Test meal - 2
Greek Yogurt Plain Fat-Free - 170g
Melon, watermelon - 300g
Red Kidney Beans -170g
Carrot, fresh, unpeeled - 200g
Berri Juice Tomato- 300mL
Test meal - 3
Ferrero Nutella Hazelnut Spread - 20g
Wholemeal & Seeds - 2 regular slices
Up&Go Energize Iced Coffee Flavour - 170g

Intervention code [1] 314700 0
Prevention
Comparator / control treatment
Reference meal - comparator
Bread, wholemeal, commercial, toasted, unfortified - 60g (2 regular slices)
butter - 7g (1 x 7g tub)
Peanut butter, crunchy, no added salt - 11g (1 x 11g tub)
chocolate flavoured milk - 250 mL
Control group
Active

Outcomes
Primary outcome [1] 320610 0
Plasma triglycerides as assessed using a blood test
Timepoint [1] 320610 0
baseline and 180 minutes post meal consumption
Primary outcome [2] 320611 0
Plasma Insulin as assessed using a blood test
Timepoint [2] 320611 0
baseline and 180 minutes post meal consumption
Secondary outcome [1] 371362 0
Blood glucose levels
Timepoint [1] 371362 0
baseline and 180 minutes post meal consumption

Eligibility
Key inclusion criteria
Inclusion criteria:
• Healthy male or female aged between 18 and 40 years old at initial assessment
• Body mass index (BMI ) between 18 and 30 Kg/m2.
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Subjects will be excluded from the intervention if they:
• Take any lipid-lowering drugs or supplements (e.g. statins, fish oil) or anti-hypertensive drugs;
• Are dieting or have any eating disorders;
• Have allergy or intolerance to any of the food products or ingredients used;
• Have a history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD;
• Have a history of diabetes, hypertension, triglycerides higher than 3 mmol/L; total cholesterol higher than 5 mmol/L;
• Have a history of the gastrointestinal disorder or liver disease;
• Smoke;
• Are pregnant or breastfeeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302343 0
University
Name [1] 302343 0
Riddet Institute
Address [1] 302343 0
Massey University
Private Bag 11 222
Palmerston North 4442
New Zealand
Country [1] 302343 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute
Address
Massey University
Private Bag 11 222
Palmerston North 4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302225 0
None
Name [1] 302225 0
Address [1] 302225 0
Country [1] 302225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303018 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 303018 0
Research and Innovation Services
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 303018 0
Australia
Date submitted for ethics approval [1] 303018 0
Approval date [1] 303018 0
31/08/2018
Ethics approval number [1] 303018 0

Summary
Brief summary
Elevated fasting plasma insulin and triglyceride levels are known to increase the risk for cardiovascular disease (CVD) and type 2 diabetes. Although the measure of fasting plasma triglyceride and insulin levels may represent a cumulative effect of the dietary habits and disease, it does not allow the understanding of the contribution of individual foods/meals to CVD risk. Therefore, the development of a postprandial measure that includes both triglycerides and insulin is warranted to understand the effect of food/meals on the development of chronic diseases. A standardised meal is used as a comparator for three isocaloric test meals of varying macronutrient composition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92182 0
Prof Manohar Garg
Address 92182 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308
Country 92182 0
Australia
Phone 92182 0
+61 2 4921 5647
Fax 92182 0
Email 92182 0
manohar.garg@newcastle.edu.au
Contact person for public queries
Name 92183 0
Prof Manohar Garg
Address 92183 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308
Country 92183 0
Australia
Phone 92183 0
+61 2 4921 5647
Fax 92183 0
Email 92183 0
manohar.garg@newcastle.edu.au
Contact person for scientific queries
Name 92184 0
Prof Manohar Garg
Address 92184 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308
Country 92184 0
Australia
Phone 92184 0
+61 2 4921 5647
Fax 92184 0
Email 92184 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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2900 0
Study protocol
Citation [1] 2900 0
Link [1] 2900 0
Email [1] 2900 0
rohith.thota@newcastle.edu.au
Other [1] 2900 0
Attachment [1] 2900 0
Type [2] 2901 0
Ethical approval
Citation [2] 2901 0
Link [2] 2901 0
Email [2] 2901 0
rohith.thota@newcastle.edu.au
Other [2] 2901 0
Attachment [2] 2901 0
Type [3] 2902 0
Informed consent form
Citation [3] 2902 0
Link [3] 2902 0
Email [3] 2902 0
rohith.thota@newcastle.edu.au
Other [3] 2902 0
Attachment [3] 2902 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary