Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000869178
Ethics application status
Approved
Date submitted
12/06/2019
Date registered
19/06/2019
Date last updated
23/09/2019
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.
Intervention code [1] 314724 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320387 0
Glucose tolerance using 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

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
Gender
Both males and females
Can healthy volunteers participate?
Yes
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).

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 glucose responses during ingestion of a mixed in healthy individuals after 7 days of high fat high calorie feeding (Parry et al 2017, Br J Nutr.) whereby area under the curve changed from 1024 ± 74 mmol/l*mins to 1138 ± 56 mmol/l*mins, we estimate that 10 participants (5 male and 5 female) are required to detect a meaningful and significant increase in meal-related glucose changes after 7 days of high fat, high calorie feeding in our study (alpha = 0.05, 99% power, large effect size). As such, acknowledging an estimated 15% dropout rate, we will recruit 12 participants.

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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 303019 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country [1] 303019 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
221 Burwood Highway, Burwood Victoria 3125 Australia
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
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

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
Gunveen.Kaur@deakin.edu.au
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
Australia
Phone 94115 0
+61 3 92468288
Fax 94115 0
Email 94115 0
Gunveen.Kaur@deakin.edu.au
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
Australia
Phone 94116 0
+61 3 92468288
Fax 94116 0
Email 94116 0
Gunveen.Kaur@deakin.edu.au

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?
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