Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000655640
Ethics application status
Approved
Date submitted
10/05/2023
Date registered
16/06/2023
Date last updated
16/06/2023
Date data sharing statement initially provided
16/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a single high-fat meal and the protective effect of naturally occurring polyphenolic compounds on artery function
Scientific title
The protective effect of naturally occurring polyphenolic compounds in a single high-fat meal on artery function in healthy young adult men
Secondary ID [1] 309508 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 329789 0
Arterial endothelial function 329790 0
Condition category
Condition code
Cardiovascular 326685 326685 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 326686 326686 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will help us assess the effect of a high-fat meal on our blood vessels (cardiovascular health) and how naturally occurring polyphenolic compounds in plant foods could potentially affect this beneficially. This will be a single-blinded, 3-armed randomised crossover interventional trial in young, apparently healthy men.

Participants will be screened via an online survey for eligibility with likely candidates invited for an in-person screening session at the BASE facility (Be Active Sleep Eat) at Monash University, Notting Hill campus. At the screening visit, anthropometry, blood pressure, endothelial function via flow mediated dilation (FMD) and fasting glucose, triglycerides and cholesterol will be measured by a trained researcher.

After completion of a physical activity questionnaire, a general demographics survey and a food record participants will be booked in for a testing visit. Each participant will complete arm 1 and 2 testing visits plus can opt-in for the third arm testing visit.

Arm 1: High-Fat milkshake + control (1g fat per kilo of bodyweight)
Arm 2: High-Fat milkshake + 26 g freeze dried blueberries + 12.24g high flavanol cocoa powder (per 75 kg of bodyweight)
Arm 3: Fasting

All interventions will be delivered face-to-face on at least two separate occasions over 7.5 hours. There is a minimum 1 week washout period between the intervention sessions. For 24 hours before testing, participants will avoid strenuous exercise and consume at least 2 L of fluids. On the morning of testing, following an overnight fast from 9 pm (water is allowed) participants will present at BASE and undergo baseline measurements, participants will then either consume the high fat meal plus additives or continue to fast. All intervention food will be consumed under supervision. After meal consumption, venous blood samples will be collected every 15 minutes for the first hour, every 30 minutes for the following two hours, and then every 60 minutes up to 6 hours following the meal. FMD and blood pressure will be measured every hour post-meal.
Intervention code [1] 325939 0
Prevention
Comparator / control treatment
To assess the effect of a high-fat meal, arm 3 (Fasting) will act as a control to arm 1 (High-Fat milkshake + control).

To assess how naturally occurring polyphenolic compounds in plant foods could potentially have a protective effect, arm 1 (High-Fat milkshake + control) will act as a control to arm 2 (High-Fat milkshake + freeze dried blueberries + high flavanol cocoa powder). The controls will consist of an isocaloric and carbohydrate-matched control powder made of maltodextrin, fructose and artificial colour and flavourings, based on results determined from detailed nutritional composition analysis.
Control group
Placebo

Outcomes
Primary outcome [1] 334567 0
Change in endothelial function determined by ultrasound scans of Flow-Mediated Dilation (FMD)
Timepoint [1] 334567 0
Completed at the screening visit (Familiarisation). For the testing visits: postprandial time course study with measurements taken at baseline and hourly up to 6 hours after the meal. There is no one time point that is the primary time point.
Secondary outcome [1] 421239 0
Change in plasma glucose concentration, measured on an Indiko Analyser
Timepoint [1] 421239 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [2] 421240 0
Change in plasma insulin concentration, measured by ELISA.
Timepoint [2] 421240 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [3] 421241 0
Change in serum cholesterol (total, HDL and LDL) concentration, measured on an Indiko Analyser.
Timepoint [3] 421241 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [4] 421242 0
Change in serum triglyceride concentration, measured on an Indiko Analyser.
Timepoint [4] 421242 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [5] 421243 0
Change in blood pressure using an automated blood pressure monitor (Omron).
Timepoint [5] 421243 0
Postprandial time course study with measurements taken at baseline and hourly up to 6 hours after the meal.
Secondary outcome [6] 421244 0
Change in serum high sensitivity C-Reactive Protein (hsCRP), measured on an Indiko Analyser.
Timepoint [6] 421244 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [7] 421245 0
Usual dietary intake (energy intake and macronutrient composition) as assessed using an open-source self-completed computerised dietary recall system Intake24
Timepoint [7] 421245 0
48-hour food record will be completed before the screening visit and before each testing visit.
Secondary outcome [8] 421246 0
Myeloperoxidase (MPO) enzyme activity in serum as assessed by colorimetric assay
Timepoint [8] 421246 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal
Secondary outcome [9] 421247 0
Usual physical activity level (MET score) as assessed using the International Physical Activity Questionnaire (IAPQ) short version
Timepoint [9] 421247 0
Completed on the screening visit and each testing day and assessing physical activity from the previous week
Secondary outcome [10] 421248 0
Long-term advanced glycation end-product (AGE) deposition in skin tissue (measurement of skin autofluorescence using an AGE Reader)
Timepoint [10] 421248 0
Single time point at screening visit
Secondary outcome [11] 421249 0
Anthropometric measurements: bodyweight in kg will be assessed using scales and height in cm will be assessed using a stadiometer and both will be used to enable calculation of body mass index (BMI).
Timepoint [11] 421249 0
Single time point at all visits
Secondary outcome [12] 421861 0
Change in plasma superoxide dismutase 1 (SOD1), measured by ELISA.
Timepoint [12] 421861 0
Postprandial time course study with venous blood samples taken at baseline and then at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min after the meal.
Secondary outcome [13] 422888 0
Waist circumference, measured in centimetres using a standard tape measure at the midpoint between the iliac crest and lowest rib.
Timepoint [13] 422888 0
Single time point at all visits
Secondary outcome [14] 422889 0
Body composition (fat mass, fat-free mass, muscle mass and total body water) will be determined using bioelectric-impedance analysis (515/514 SECA Medical Body Composition Analyser)
Timepoint [14] 422889 0
Single time point at all visits

Eligibility
Key inclusion criteria
Young (More than 18 years old and less than 31 years old), apparently healthy, non-smoking males with a BMI between 18.5 or above 27 kg/m2.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Less than 18 years of age or older than 31 years of age
- Body mass index (BMI) less than 18.5 or above 27 kg/m2
- Be a current smoker or have ceased smoking within the past six months
- Biological sex is female
- Individuals who have an arteriovenous fistula or implantable cardiac defibrillator/cardiac pacemaker
- Fasting triglycerides above 1.7 mmol/L and fasting glucose above 7 mmol/L
- Blood pressure below 90/60 or above 140/90 mmHg
- A confirmed diagnosis of T2D or a diagnosis of lipid-related disorder (e.g hypercholesterolemia, fatty liver); anyone on lipid lowering medication or other medications.
- People who do not wish to have blood samples collected or cannot tolerate the sight of blood
- Individuals with dietary allergies that prevent them from consuming study meals
- People who cannot read or write English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by using letter codes on powders and controls in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed using computerized sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: Based on alpha = 0.05, a power of 80% and an estimated effect size of 0.25 or greater maximum change in FMD, 18 participants are required.

Analyses: FMD analysis will be conducted according to the most recent guidelines. All data will be tested for normality using the Shapiro-Wilk test, and non-normally distributed variables will be log-transformed prior to analysis. A mixed between-within subjects analysis of variance (ANOVA) will be used to assess the effect of both the high fat meal and the naturally occurring polyphenolic compounds.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313702 0
University
Name [1] 313702 0
Monash University
Country [1] 313702 0
Australia
Primary sponsor type
Individual
Name
Gary Williamson
Address
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 315524 0
Individual
Name [1] 315524 0
Juanita Fewkes
Address [1] 315524 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country [1] 315524 0
Australia
Secondary sponsor category [2] 315525 0
Individual
Name [2] 315525 0
Aimee Dordevic
Address [2] 315525 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country [2] 315525 0
Australia
Secondary sponsor category [3] 315526 0
Individual
Name [3] 315526 0
Nicole Kellow
Address [3] 315526 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country [3] 315526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312870 0
Monash University Human Research Ethics
Ethics committee address [1] 312870 0
Ethics committee country [1] 312870 0
Australia
Date submitted for ethics approval [1] 312870 0
13/03/2023
Approval date [1] 312870 0
22/03/2023
Ethics approval number [1] 312870 0
24593

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

Contacts
Principal investigator
Name 126178 0
Prof Gary Williamson
Address 126178 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 126178 0
Australia
Phone 126178 0
+61 3 9905 6649
Fax 126178 0
Email 126178 0
[email protected]
Contact person for public queries
Name 126179 0
Juanita Fewkes
Address 126179 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 126179 0
Australia
Phone 126179 0
+61 3 9902 4298
Fax 126179 0
Email 126179 0
[email protected]
Contact person for scientific queries
Name 126180 0
Juanita Fewkes
Address 126180 0
Department of Nutrition, Dietetics and Food, Monash University
Be Active Sleep & Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill VIC 3168
Country 126180 0
Australia
Phone 126180 0
+61 3 9902 4298
Fax 126180 0
Email 126180 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 raw data will not be shared in a data repository, registry or open source platform because it will all be made available via publications/thesis in grouped de-identied form.


What supporting documents are/will be available?

No Supporting Document Provided



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.