Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001219774
Ethics application status
Approved
Date submitted
6/09/2022
Date registered
9/09/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
9/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
GlucoTRIG: measuring the impact of high carbohydrate and high fat composite meals on postprandial insulin and triglyceride responses in healthy adults – a randomised, controlled, crossover trial
Scientific title
GlucoTRIG: measuring the impact of high carbohydrate and high fat composite meals on postprandial insulin and triglyceride responses in healthy adults – a randomised, controlled, crossover trial
Secondary ID [1] 305312 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin resistance 323628 0
Hyperlipidemia 323629 0
Condition category
Condition code
Diet and Nutrition 321163 321163 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 324693 324693 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is an acute, randomised, crossover design involving 15 healthy participants (male or female) and consisting of three treatment arms. All treatment arms will be isocaloric and only differing in macronutrient compositions. All participants will undergo all three treatment arms.

The three treatment arms consist of (1) a reference meal of 480 kcal energy, 19.8g proteins (16.5%), 13.9g fats (26.1%), 66.1g carbohydrates (55.1%), and 3.1g fibre (0.6%); (2) a high-carbohydrate, low-fat test meal consisting of 479 kcal energy, 20g proteins (16.7%), 6.7g fats (12.6%), 81.3g carbohydrates (67.9%), and 4.1g fibre (0.9%); and (3) a low-carbohydrate, high-fat test meal consisting of 479 kcal energy, 22.9g proteins (19.1%), 27.1g fats (50.9%), 34.2g carbohydrates (28.6%), and 3.5g fibre (1.1%).

Participants will be asked to complete a consent form for participation, a brief medical questionnaire, a health screening questionnaire, eating attitudes testing questionnaire, and a physical activity questionnaire at the screening visit. Screening visit will involve taking anthropometric measurements (weight, height, body muscle and fat mass, etc.), blood pressure, and a finger prick test to obtain fasting lipid profile and glycated haemoglobin A1c (HbA1c) for eligibility.

Each study visit comprises 3.5 hours where eligible participants will arrive at the clinical facility at Massey University after an overnight fast (at least 12 hours). At each study visit, participants will be asked to provide a completed 24 h food recall record to ensure compliance and that there are no significant changes to their diet throughout the study. At each study visit, a venous blood sample (18 mL) for fasting glucose, insulin and triglycerides at time point 0 min (baseline) will be collected. They will then be given a meal to consume within 20 minutes. The meal ingestion will be timed and participants will have to finish their meal within 20 minutes. The plate will be visually checked to ensure there are no leftovers remaining. Following 3-hour post meal, another venous blood sample (18 mL) will be collected at 180 min for the same measurements.

Blood draws will be taken by having the participant lie in a supine position and blood samples taken via venipuncture on the antecubital fossa region of the arm into blood vacutainers. Blood collected will be immediately centrifuged and aliquot for storage at -80degC until analysis.

Primary measure includes measuring postprandial triglycerides and insulin levels after consuming reference and test meals on separate occasions. Postprandial glucose and inflammatory markers including c-reactive protein (CRP), interleukin-6 (IL-6) as a secondary measure will also be taken. The data will be used to calculate the GlucoTRIG value of each meal to rank the healthiness of each meal.

There will be at least a week of washout between each visit. Participants will be instructed to maintain a consistent diet without any dietary alterations throughout the duration of the study. They are to also abstain from alcohol and beverages such as teas, coffees, and energy drinks (both caffeinated and decaffeinated), all health supplements, and strenuous activity during the 24h period before each study visit.
Intervention code [1] 321721 0
Prevention
Comparator / control treatment
This is a crossover design where participants act as their own control. The reference meal is also treated as a form of control where the test meals will be compared to the reference meal.

The reference meal consists of 480 kcal energy, 19.8g proteins (16.5%), 13.9g fats (26.1%), 66.1g carbohydrates (55.1%), and 3.1g fibre (0.6%).
Control group
Active

Outcomes
Primary outcome [1] 328957 0
Postprandial triglycerides (obtained from venous blood sample)
Timepoint [1] 328957 0
Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal
Primary outcome [2] 328958 0
Postprandial insulin levels (obtained from venous blood sample)
Timepoint [2] 328958 0
Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal
Secondary outcome [1] 400945 0
Postprandial blood glucose (obtained from venous blood sample)
Timepoint [1] 400945 0
Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal
Secondary outcome [2] 413676 0
Inflammatory markers such as c-reactive protein (CRP) and interleukin-6 (IL-6). Blood samples for CRP test will be collected in heparin vacutainer and centrifuged to obtain plasma, and analysed using latex-enhanced nephelometry. Blood samples for IL-6 measurement will be collected in EDTA vacutainer and centrifuged to obtain plasma, and analysed using the IL-6 ELISA kit.
Timepoint [2] 413676 0
Time point: 0 min (baseline) prior to starting meal, and 180 min after starting meal

Eligibility
Key inclusion criteria
• Healthy male or female
• Ages 18-40 years old
• BMI 18.5-24.9 kg/m2 (NZ healthy BMI range, could include to 29.9 kg/m2 overweight participants)
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Take any glucose- or lipid-lowering drugs or supplements (e.g. statins, fibrates),
• Take any anti-hypertensive drugs (e.g. thiazide diuretics, angiotensin converting enzyme (ACE) inhibitors (or angiotensin receptor blocker (ARB), ß-blockers, calcium channel blockers), or any other medications known to affect triglyceride concentrations (e.g. antipsychotic, ß-adrenergic blockers, protease inhibitors, interferon, raloxifene, retinoic acid drugs, sirolimus, steroids or thiazides),
• Chronic use of any dietary supplementation (antioxidants, vitamins/minerals, fish oil)
• Are dieting or have any dietary restrictions or eating disorders including alcohol or drug abuse,
• Have allergy or intolerance to food products or ingredients used in the study,
• Any inflammatory condition or recent history of chronic health condition,
• Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD,
• Have history of diabetes, hypertension, triglycerides higher than 3 mmol/L; total cholesterol higher than 5 mmol/L;
• Have history of gastrointestinal disorder or liver disease,
• Smoke,
• 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)
Allocation concealment will be applied to the study. Each of the three treatment meals will be allocated a random number and sequence generated by the computer, and concealed in an opaque envelope till the day of assignment for each participant. Each participant will not know in which order or what type of meal they will be provided at each visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to each of the meals will be performed using a randomisation table created by computer software (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
• Postprandial curves for different test meals will be compared using linear mixed model repeated measures (IBM SPSS v28, IBM corporation, New York, USA) to determine the difference in peak triglyceride in plasma and return to fasted state. A p value of =0.05 is considered to be significant (95% confidence level)
• In addition, maximum postprandial concentration (peak concentration) and the time length for its appearance as well as the total change from fasting to peak concentration will be measured and compared
• Data will be presented as mean ± SEM
• Results will be used to calculate the GlucoTRIG value of each meal. GlucoTRIG value will be measured as (plasma triglycerides180min x plasma insulin180min)-(plasma triglycerides0min x plasma insulin0min).
• The final GlucoTRIG value of the test meals will be expressed as percent mean reference meal value. Differences in the final values between the test meals will also be compared using linear mixed model repeated measures
• Bonferroni post-hoc test for multiple comparisons will be carried out if applicable

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2022
Actual
Date of last participant enrolment
Anticipated
15/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 24119 0
New Zealand
State/province [1] 24119 0
Auckland

Funding & Sponsors
Funding source category [1] 309679 0
University
Name [1] 309679 0
Riddet Institute, Massey University
Country [1] 309679 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute, Massey University
Country
New Zealand
Secondary sponsor category [1] 310701 0
None
Name [1] 310701 0
None
Country [1] 310701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309446 0
Massey University Human Ethics Committee
Ethics committee address [1] 309446 0
Ethics committee country [1] 309446 0
New Zealand
Date submitted for ethics approval [1] 309446 0
17/05/2022
Approval date [1] 309446 0
02/09/2022
Ethics approval number [1] 309446 0
SOA 22/34

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 114190 0
Dr Wen Xin Janice Lim
Address 114190 0
Riddet Institute Massey University Auckland (East Precinct) Sir Neil Waters Extension (SNWE) Level 3 Albany Expressway (SH17) Albany 0632 New Zealand
Country 114190 0
New Zealand
Phone 114190 0
+64 02108903957
Fax 114190 0
Email 114190 0
w.x.j.lim@massey.ac.nz
Contact person for public queries
Name 114191 0
Manohar Garg
Address 114191 0
Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia
Country 114191 0
Australia
Phone 114191 0
+61 02 4921 5647
Fax 114191 0
Email 114191 0
manohar.garg@newcastle.edu.au
Contact person for scientific queries
Name 114192 0
Manohar Garg
Address 114192 0
Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Callaghan, NSW 2308, Australia
Country 114192 0
Australia
Phone 114192 0
+61 02 4921 5647
Fax 114192 0
Email 114192 0
manohar.garg@newcastle.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor


Conditions for requesting access:
• -

What individual participant data might be shared?
• Only de-identified participant data underlying published results will be shared


What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal, for IPD meta-analyses


When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date


To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator. The Principal Investigator can be contacted at w.x.j.lim@massey.ac.nz


Are there extra considerations when requesting access to individual participant data?
No


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.