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Trial registered on ANZCTR


Registration number
ACTRN12624001216505
Ethics application status
Approved
Date submitted
5/09/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Date data sharing statement initially provided
4/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of foods rich in omega-3 fats on muscle microvascular blood flow.
Scientific title
Effect of foods rich in omega-3 fats on muscle microvascular blood flow in healthy adults consuming a high calorie diet.
Secondary ID [1] 312812 0
None
Universal Trial Number (UTN)
Trial acronym
HCHF N3 D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glucose tolerance 334885 0
Cardiometabolic outcomes 334887 0
Condition category
Condition code
Metabolic and Endocrine 331434 331434 0 0
Diabetes
Cardiovascular 331435 331435 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 carbohydrates, 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 fish, nuts, sesame snaps, omega-3 enriched eggs). 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. Testing days in the lab will involve drinking a mixed meal drink (chocolate milk shake), providing blood samples and undergoing ultrasound scans. The mixed meal drink is 250ml milk shake that provides 1306.4kj energy (39.6g of carbohydrate, 20.6g of protein and 5.3g of fat).
Intervention code [1] 329352 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339190 0
Insulin response following the 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 at each visit.
Timepoint [1] 339190 0
Insulin will be measured post intervention commencement on Day 0, Day 4, and Day 8 (primary timepoint) of the intervention at 0, 15, 30, 60, 90 and 120 mins after consuming the chocolate milk shake at each visit.
Primary outcome [2] 339191 0
Microvascular blood flow following the mixed meal challenge. This is measured using infusion of a safe and approved contrast agent and using ultrasound imaging in fasted state and at 60 and 120 min following the intake of the meal.
Timepoint [2] 339191 0
Microvascular blood flow will be measured post intervention commencement on Day 0, Day 4, and Day 8 (primary timepoint) of the intervention at 0, 15, 30, 60, 90 and 120 mins after consuming the chocolate milk shake at each visit.
Secondary outcome [1] 439005 0
Total body fat and lean body mass. These are measured in fasted state.
Timepoint [1] 439005 0
Day 0, Day 4 and Day 8 post intervention commencement,
Secondary outcome [2] 439006 0
Femoral artery diameter and blood velocity as composite secondary outcome. These are measured in fasted state and at 60 and 120 min following the intake of the meal.
Timepoint [2] 439006 0
Day 0, Day 4 and Day 8 post intervention commencement in fasted state and at 60 and 120 min following the intake of the chocolate milk shake.
Secondary outcome [3] 439008 0
Central systolic and diastolic pressure, pulse pressure, and augmentation index (AIx) as composite secondary outcomes. Central systolic and diastolic pressures are measured in fasted state and at 60 and 120 min following the intake of the meal. Augmentation index is measured in fasted state.
Timepoint [3] 439008 0
Day 0, Day 4 and Day 8 post intervention commencement in fasted state and in 30 min intervals for 2 hours following the intake of the chocolate milk shake.
Secondary outcome [4] 439009 0
Inflammatory markers - These are measured in blood samples collected using an intravenous catheter. The blood samples will be collected in fasted state and in 30 min intervals for 2 hours following the intake of the meal.
Timepoint [4] 439009 0
Day 0, Day 4 and Day 8 post intervention commencement in fasted state
Secondary outcome [5] 439010 0
Resting metabolic rate. This is measured in fasted state and in 1 hour intervals for 2 hours following the intake of the meal.
Timepoint [5] 439010 0
Day 0, Day 4 and Day 8 post intervention commencement in 1-hour intervals for 2 hours following the intake of the meal
Secondary outcome [6] 439624 0
Flow mediated dilation in brachial artery.
Timepoint [6] 439624 0
Day 0, Day 4 and Day 8 post intervention. These are measured in fasted state and at 60 and 120 min following the intake of the meal.
Secondary outcome [7] 439625 0
Gut derived hormones.
Timepoint [7] 439625 0
These are measured in blood samples collected using an intravenous catheter. The blood samples will be collected in fasted state and in 30 min intervals for 2 hours following the intake of the meal on day 0, day 4 and day 8 (post intervention commencement).
Secondary outcome [8] 439626 0
Lipid markers.
Timepoint [8] 439626 0
These are measured in blood samples collected using an intravenous catheter. The blood samples will be collected in fasted state and in 30 min intervals for 2 hours following the intake of the meal on day 0, day 4 and day 8 (post intervention commencement).

Eligibility
Key inclusion criteria
Healthy males and females aged 18-45 years with a normal body mass index (BMI) [between 18 and 24.9 kg/m2, considered normal weight according to the World Health Organization].

Normotensive [seated brachial blood pressure less than 140/90 mmHg].

Have no dietary allergies or food intolerances.

Have given signed informed consent to participate in the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who cannot read and communicate in English.

People with any known food allergies.

Regular smokers, or who have smoked in the past 10 years or/and smoked for more than 10 years will be excluded.

History of severe liver disease, any vascular diseases or cardiovascular disease (previous stroke or heart attack), or T2D or who have a family history of T2D (parents with T2D).

Pregnant or lactating women.

People on a high fat diet (e.g. ketogenic diet) or a vegan/vegetarian diet.

People consuming fish>2 times a week or take omega-3 supplements (supplementation for 2 or more days a week for more than a week, within the past 3 months).

People exercising more than the current guidelines for physical activity (>5 hours of moderate intensity physical activity or > 2.5 hours of vigorous intensity physical activity per week).

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317251 0
University
Name [1] 317251 0
IPAN Seed funding from Deakin University
Country [1] 317251 0
Australia
Primary sponsor type
University
Name
Deakin university
Address
Country
Australia
Secondary sponsor category [1] 319528 0
None
Name [1] 319528 0
Address [1] 319528 0
Country [1] 319528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315986 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315986 0
Ethics committee country [1] 315986 0
Australia
Date submitted for ethics approval [1] 315986 0
24/07/2024
Approval date [1] 315986 0
06/09/2024
Ethics approval number [1] 315986 0

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

Contacts
Principal investigator
Name 136426 0
Dr Gunveen Kaur
Address 136426 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 136426 0
Australia
Phone 136426 0
+61 3 92468288
Fax 136426 0
Email 136426 0
Gunveen.Kaur@deakin.edu.au
Contact person for public queries
Name 136427 0
Gunveen Kaur
Address 136427 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 136427 0
Australia
Phone 136427 0
+61 3 92468288
Fax 136427 0
Email 136427 0
Gunveen.Kaur@deakin.edu.au
Contact person for scientific queries
Name 136428 0
Gunveen Kaur
Address 136428 0
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 136428 0
Australia
Phone 136428 0
+61 3 92468288
Fax 136428 0
Email 136428 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24162Study protocol    388342-(Uploaded-05-09-2024-12-57-44)-projectdescriptionprotocol GKaur_27.8.24.docx
24163Informed consent form    388342-(Uploaded-05-09-2024-12-57-55)-PLS-Consent form GKaur_27.8.24.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.