ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Type 2 diabetes

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

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]

Plasma triglycerides as assessed using a blood test

Timepoint [1]

baseline and 180 minutes post meal consumption

Primary outcome [2]

Plasma Insulin as assessed using a blood test

Timepoint [2]

baseline and 180 minutes post meal consumption

Secondary outcome [1]

Blood glucose levels

Timepoint [1]

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

Sex

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

11/09/2018

Date of last participant enrolment

Anticipated

Actual

9/11/2018

Date of last data collection

Anticipated

Actual

16/11/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Riddet Institute

Address [1]

Massey University
Private Bag 11 222
Palmerston North 4442
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research and Innovation Services 
Research Integrity Unit 
The University of Newcastle 
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/08/2018

Ethics approval number [1]

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

Prof Manohar Garg

Address

Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

[email protected]

Contact person for public queries

Name

Manohar Garg

Address

Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

[email protected]

Contact person for scientific queries

Name

Manohar Garg

Address

Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
Callaghan, NSW 2308

Country

Australia

Phone

+61 2 4921 5647

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
2900	Study protocol	[email protected]
2901	Ethical approval	[email protected]
2902	Informed consent form	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	GlucoTRIG: A novel tool to determine the nutritional quality of foods and meals in general population.	2020	https://dx.doi.org/10.1186/s12944-020-01268-w

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically