Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001365954
Ethics application status
Approved
Date submitted
28/08/2020
Date registered
18/12/2020
Date last updated
18/12/2020
Date data sharing statement initially provided
18/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A high-fat meal challenge study exposing non-traditional risk factors for Type 2 Diabetes for Chinese Australians
Scientific title
High-fat meal challenge to assess lipid metabolism in Chinese Australians at risk of Type 2 Diabetes Mellitus: A non-randomised crossover trial
Secondary ID [1] 301912 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 318429 0
Cardiovascular Diseases 318706 0
Condition category
Condition code
Diet and Nutrition 316435 316435 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 317555 317555 0 0
Diabetes
Cardiovascular 317556 317556 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 2-armed crossover intervention trial. The aim of the intervention is to challenge the postprandial lipid metabolism participants to determine if there is a difference between Chinese and Caucasian participants.

Participants will be given two separate meal challenges.

The first will be a high-fat meal challenge (with approximately 53% fat, 40% carb, 6% protein) and the second (on a separate study visit) will be a high-carbohydrate meal challenge (70% carb, 24% fat and 6% protein) .
Each meal challenge will include 2 meals per study visit (one at 0 hours and another at 4 hours). The second meal at each visit will reflect a standard fat and carbohydrate composition. Participants will be asked to fast for 12 hours prior to each visit and consume a standard low-fat meal the evening prior to the visit.
The intervention will be delivered by a trained researcher accompanied by a trained nurse with expertise in cannula blood draws.
Both interventions will be delivered face-to-face on two separate occasions over 7 hours. The intervention will take place at our lab facility with a minimum 1 week washout period between the two intervention sessions.
Intervention code [1] 318198 0
Early detection / Screening
Comparator / control treatment
The control group will Caucasian participants matched based on age and waist circumference who will receive the same intervention meals as the Chinese participants.
Control group
Active

Outcomes
Primary outcome [1] 324587 0
The primary outcome will be the difference in the postprandial triglycerides incremental area under the curve (iAUC) between the two groups. This will be assessed based on plasma blood samples taken over the 6 hours postprandial for each participant.
Timepoint [1] 324587 0
The entire 6 hours period after ingestion of the first test meal for each study visit

Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [1] 385119 0
Differences in postprandial and/or fasting glucose between testing groups and test meals.
Timepoint [1] 385119 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [2] 386248 0
Fecal microbiota composition

Bacterial diversity profiling: gDNA extracted from stool samples will be amplified by PCR using validated fusion primers for the 16SrRNA: 341F - 806R region. Bar-coded amplicons will then be pooled and sequenced on the MiSeq platform utilising Illumina’s Paired End Chemistry.

Bioinformatics: Demultiplexed paired-end reads will be received from the sequencing centre in FastQ format and imported into QIIME2 (version 2019.7). Overall run quality will be assessed with FastQC (version 0.11.5). Paired end reads will be denoised, filtered and trimmed using the dada2 plugin. Amplicon sequence variants (ASVs) will be classified using the greengenes (version 13_8) database. De novo phylogenetic trees will be created using the align-to-tree-mafft-fastree plugin in QIIME2. Taxa barplots, heatmaps, alpha and beta diversity analyses will be completed in QIIME2 using rarefied counts. Beta-diversity will be visualised with principal coordinates analysis (PCoA) generated within QIIME2 using the EMPeror graphics package.
Timepoint [2] 386248 0
The day before the second testing visit.
Secondary outcome [3] 388498 0
The time course kinetics of total cholesterol will also be examined. Lipidomics will provide a descriptive overview of lipid profiles in both groups. This will aim to identify novel biomarkers.
Timepoint [3] 388498 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [4] 389924 0
Differences in postprandial and/or fasting insulin between testing groups and test meals.
Timepoint [4] 389924 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [5] 389925 0
The time course kinetics of HDL will also be examined. Lipidomics will provide a descriptive overview of lipid profiles in both groups. This will aim to identify novel biomarkers.
Timepoint [5] 389925 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [6] 389926 0
The time course kinetics of LDL cholesterol, will also be examined. Lipidomics will provide a descriptive overview of lipid profiles in both groups. This will aim to identify novel biomarkers.
Timepoint [6] 389926 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..
Secondary outcome [7] 389927 0
The time course kinetics of chylomicron particles will also be examined.
Timepoint [7] 389927 0
Twelve blood samples will be taken at baseline, 15, 30, 45, 60, 90. 120. 180, 240, 270, 300, and 360 minutes post ingestion..

Eligibility
Key inclusion criteria
Group 1: Adult migrants of Chinese ethnicity who screen at high risk of T2D according to the AUSDRISK tool.

Group 2:Adult Caucasians who screen at high risk of T2D according to the AUSDRISK tool
Minimum age
35 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A confirmed diagnosis of T2D or a diagnosis of lipid-related disorder (e.g hypercholesterolemia, fatty liver); anyone on lipid lowering medication or other medications and smokers known to interfere with normal lipid metabolism.
Participants with abnormal fasting triglycerides and fasting glucose above 7mmol/L(this is indicative of diabetes)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot study, sample size calculations were not completed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2021
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306327 0
Charities/Societies/Foundations
Name [1] 306327 0
Diabetes Australia
Country [1] 306327 0
Australia
Primary sponsor type
Individual
Name
Catherine Huggins
Address
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC, 3168
Country
Australia
Secondary sponsor category [1] 306823 0
Individual
Name [1] 306823 0
Sarah Lee
Address [1] 306823 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC, 3168
Country [1] 306823 0
Australia
Secondary sponsor category [2] 306833 0
Individual
Name [2] 306833 0
Nicole Kellow
Address [2] 306833 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC, 3168
Country [2] 306833 0
Australia
Secondary sponsor category [3] 306834 0
Individual
Name [3] 306834 0
Tammie Choi
Address [3] 306834 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd
Notting Hill, VIC, 3168
Country [3] 306834 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306538 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 306538 0
Ethics committee country [1] 306538 0
Australia
Date submitted for ethics approval [1] 306538 0
24/02/2020
Approval date [1] 306538 0
25/02/2020
Ethics approval number [1] 306538 0
22948

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

Contacts
Principal investigator
Name 104210 0
Dr Catherine Huggins
Address 104210 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd.
Notting Hill, VIC, 3168
Country 104210 0
Australia
Phone 104210 0
+61 3 99024269
Fax 104210 0
Email 104210 0
[email protected]
Contact person for public queries
Name 104211 0
Catherine Huggins
Address 104211 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd.
Notting Hill, VIC, 3168
Country 104211 0
Australia
Phone 104211 0
+61 3 99024269
Fax 104211 0
Email 104211 0
[email protected]
Contact person for scientific queries
Name 104212 0
Catherine Huggins
Address 104212 0
BASE Facility, Monash University
Level 1, 264 Ferntree Gully Rd.
Notting Hill, VIC, 3168
Country 104212 0
Australia
Phone 104212 0
+61 3 99024269
Fax 104212 0
Email 104212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
After publication of results, no end date.
Available to whom?
Researchers who have an ethically approved project proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator who can be contacted at:
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8647Ethical approval  [email protected] 380288-(Uploaded-21-08-2020-11-06-56)-Study-related document.pdf
8983Statistical analysis plan  [email protected]
8984Clinical study report  [email protected]
8985Analytic code  [email protected]



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.