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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]

None

Universal Trial Number (UTN)

Trial acronym

HCHF N3 D

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Glucose tolerance

Cardiometabolic outcomes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Cardiovascular

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]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

Total body fat and lean body mass. These are measured in fasted state.

Timepoint [1]

Day 0, Day 4 and Day 8 post intervention commencement,

Secondary outcome [2]

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]

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]

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]

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]

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]

Day 0, Day 4 and Day 8 post intervention commencement in fasted state

Secondary outcome [5]

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]

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]

Flow mediated dilation in brachial artery.

Timepoint [6]

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]

Gut derived hormones.

Timepoint [7]

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]

Lipid markers.

Timepoint [8]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

IPAN Seed funding from Deakin University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Deakin university

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/07/2024

Approval date [1]

06/09/2024

Ethics approval number [1]

Summary

Brief summary

Poor dietary patterns such as a high-calorie, high-fat (HCHF) diet can contribute to insulin resistance (IR), which is a condition where body does not respond to insulin as it should, and eventually lead to type 2 diabetes (T2D). Several human studies have confirmed that even 3-7 days of a HCHF diet impairs glucose metabolism, that is it impairs the ability of the body to remove glucose from the blood stream for energy storage and/or energy production. Our team has recently completed a human study (funded by Diabetes Australia, Ethics No: 2019-014) that showed 7-days of a HCHF diet in 14 healthy individuals led to increased meal-induced insulin concentrations within 3 days, followed by reduced meal-induced blood flow in the smallest capillaries of the muscle, also known as muscle microvascular blood flow after 7 days, compared to pre-intervention. However, the above-mentioned studies focused on saturated fat as their main source of fat. Whether the incorporation of high omega-3 polyunsaturated fats into a HCHF diet may protect against HCHF diet-induced hyperinsulinemia and impairments in skeletal muscle microvascular blood flow in healthy humans is not known and is the aim of the current study. We hypothesise that increasing omega-3 fat content in diet will protects against high fat diet-induced ‘early’ vascular impairments.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Gunveen Kaur

Address

Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 92468288

Fax

[email protected]

Contact person for public queries

Name

Gunveen Kaur

Address

Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 92468288

Fax

[email protected]

Contact person for scientific queries

Name

Gunveen Kaur

Address

Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 92468288

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24162	Study protocol					388342-(Uploaded-05-09-2024-12-57-44)-projectdescriptionprotocol GKaur_27.8.24.docx
24163	Informed 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.

Trial Review

Documents added manually

Documents added automatically