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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
Trial acronym
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
Cardiovascular 311685 311685 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
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
Comparator / control treatment
No control group
Control group

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 and Day 8
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 and Day 8
Secondary outcome [1] 371435 0
Body fat percentage using a DEXA scan
Timepoint [1] 371435 0
Day 0 and Day 8

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
• 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
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
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 303019 0
Name [1] 303019 0
IPAN Seed funding from Deakin University
Address [1] 303019 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country [1] 303019 0
Primary sponsor type
Deakin University
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Secondary sponsor category [1] 302996 0
Name [1] 302996 0
Address [1] 302996 0
Country [1] 302996 0

Ethics approval
Ethics application status
Ethics committee name [1] 303568 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 303568 0
221 Burwood Highway, Burwood Victoria 3125 Australia
Ethics committee country [1] 303568 0
Date submitted for ethics approval [1] 303568 0
Approval date [1] 303568 0
Ethics approval number [1] 303568 0

Brief summary
Previous studies have shown that short term (3-7days) overfeeding and overfeeding with high fat (with predominantly saturated fat) can lead to increased fasting glucose, impaired glucose tolerance as well as impaired insulin sensitivity in humans. But it is not known if the impaired glucose tolerance induced by short term high fat overfeeding is linked to impaired microvascular blood flow in skeletal muscle and adipose tissue. This is what we aim to test in this study. We hypothesise that 7 days of overfeeding will impair skeletal muscle and adipose microvascular blood flow and contribute to glucose tolerance.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 2323 0
Informed consent form
Citation [1] 2323 0
Link [1] 2323 0
Email [1] 2323 0
Other [1] 2323 0
Summary results
No Results