Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000869178
Ethics application status
Approved
Date submitted
12/06/2019
Date registered
19/06/2019
Date last updated
21/02/2023
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does short term high fat, high calorie feeding impair blood flow to the muscles in healthy people?
Scientific title
Does short term high fat, high calorie feeding impair cardiometabolic outcomes in healthy people?
Secondary ID [1] 298474 0
None
Universal Trial Number (UTN)
U1111-1235-1706
Trial acronym
HCHFD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiometabolic outcomes 313246 0
Glucose tolerance 313247 0
Condition category
Condition code
Metabolic and Endocrine 311684 311684 0 0
Diabetes
Cardiovascular 311685 311685 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High calorie, high fat feeding for 7 days in healthy people. This will include 50% higher energy intake than usual with energy 30% from CHO, 50% from fat and 20% from Protein. The participants will be required to consume their usual diet plus the snacks provided by the investigatory team (including biscuits, chocolate bars, yoghurt and use of coconut oil). The dietary intervention will be overseen by the team dietitian. The participants will be required to record the snacks consumed each day on a checklist provided. The participants will also need to provide one day food diary before the pre and post fasting tests.
Intervention code [1] 314724 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320387 0
Insulin response during a Mixed Meal Challenge. This involves participants consuming a drink similar to a protein shake and giving blood samples at 0, 15, 30, 60, 90 and 120 mins.
Timepoint [1] 320387 0
Day 0, Day 4 and Day 8 (primary time point)
Primary outcome [2] 320446 0
Microvascular blood flow using ultrasound technique. This involves infusion of a safe and approved contrast agent and placing an ultrasound probe on area of interest (arm) and imaging.
Timepoint [2] 320446 0
Day 0, Day 4 and Day 8 (primary time point)
Secondary outcome [1] 371435 0
Body fat percentage using a DEXA scan
Timepoint [1] 371435 0
Day 0, Day 4 and Day 8 (primary time point)

Eligibility
Key inclusion criteria
• Age 18-45 years
• BMI 18-24.9 Kg/m2.
• Normotensive (seated brachial blood pressure <140/90 mmHg).
• Have given signed informed consent to participate in the study.
• Have no known food allergies.
• Have been weight stable for past 3 months.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Update
• Not meeting the inclusion criteria outlined above
• Smoking status – regular smoker in the last 10 years and/or >10 years of smoking history
• History of severe liver disease, any vascular or cardiovascular disease or type 2 diabetes
• Pregnancy/lactation
• Family history of type 2 diabetes (i.e. a parent with type 2 diabetes).
• Person on a high fat diet (e.g. keto diet).
• Person on a high saturated fat diet (>18% energy from saturated fat).

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the data of insulin responses from the first 3 participants , to detect an increase in the insulin area under the time curve from 2510.7uU/ml*2 hours with a standard deviation of 717.9 to 3217.9uU/ml*2 hours with a standard deviation of 1068.3, 16 participants are needed with an alpha of 0.05 and a power of 80%. We will recruit 20 people to allow for a 15-20% drop-out rate.

Student paired t-test will be used to compare endpoint measurements pre- and post-intervention. Two-way repeated-measures ANOVA followed by a suitable post hoc test will be used for all continuous variables. Significance will be set at P < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2019
Actual
30/07/2019
Date of last participant enrolment
Anticipated
29/10/2021
Actual
7/02/2023
Date of last data collection
Anticipated
5/11/2021
Actual
21/02/2023
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303019 0
University
Name [1] 303019 0
IPAN Seed funding from Deakin University
Country [1] 303019 0
Australia
Funding source category [2] 313252 0
Charities/Societies/Foundations
Name [2] 313252 0
Diabetes Australia
Country [2] 313252 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 302996 0
None
Name [1] 302996 0
Address [1] 302996 0
Country [1] 302996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303568 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 303568 0
Ethics committee country [1] 303568 0
Australia
Date submitted for ethics approval [1] 303568 0
Approval date [1] 303568 0
19/03/2019
Ethics approval number [1] 303568 0
2019-014

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

Contacts
Principal investigator
Name 94114 0
Dr Gunveen Kaur
Address 94114 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 94114 0
Australia
Phone 94114 0
+61 3 92468288
Fax 94114 0
Email 94114 0
[email protected]
Contact person for public queries
Name 94115 0
Gunveen Kaur
Address 94115 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 94115 0
Australia
Phone 94115 0
+61 3 92468288
Fax 94115 0
Email 94115 0
[email protected]
Contact person for scientific queries
Name 94116 0
Gunveen Kaur
Address 94116 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 94116 0
Australia
Phone 94116 0
+61 3 92468288
Fax 94116 0
Email 94116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The results will be published in a journal article. But due to confidentiality we will be not providing individual data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2323Informed consent form    377764-(Uploaded-14-03-2022-13-39-11)-Study-related document.docx



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.