Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001039572
Ethics application status
Approved
Date submitted
14/08/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the Impact of Blueberries on Postprandial Oxidative Stress After a High-Fat High-Carbohydrate Meal in Young Healthy Men
Scientific title
Assessing the Effect of Incorporating Freeze-Dried Blueberries in a High-Fat High-Carbohydrate Meal on Postprandial Oxidative Stress in Young Healthy Men
Secondary ID [1] 312735 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 334763 0
Condition category
Condition code
Metabolic and Endocrine 331321 331321 0 0
Metabolic disorders
Diet and Nutrition 331322 331322 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a double-blinded, 3-armed crossover, randomized postprandial trial, involving healthy male participants to make three visits to the testing facility. During each visit, participants will receive one of the following:

1. A high-fat high-carbohydrate milkshake without freeze-dried blueberries
2. A high-fat high-carbohydrate milkshake with a low dose of freeze-dried blueberries (15 g)
3. A high-fat high-carbohydrate milkshake with a high dose of freeze-dried blueberries (30 g)

On the testing visits, the participants will attend the testing facility from 9.00 am to 5.00 pm. Participants will arrive to this visit following an overnight fast after consuming regular dinner between 7.00 and 9.00 pm. Participants will also be asked to maintain their regular diet and avoid strenuous exercise for the 24 hours before the beginning of the testing session. Participants will receive reminders via text message prior to the testing session to remind them of these requirements.

During the first testing visit, participants will complete a 24-hour food recall, and have their height, weight, waist circumference, body composition, and blood pressure measured.

For all three testing visits, a cannula will be inserted into a vein in the participant's arm by a nurse or trained researcher for multiple blood draws. Blood samples will be collected during the 2 hours before and 6 hours following meal consumption. Blood samples will be collected every 60 minutes during the 2 hours before food consumption. Following a two-hour run-in period, including venous blood collection, participants are given a high-fat high-carbohydrate meal in the form of a milkshake to consume within 10 minutes (time 0). The milkshakes will contain either no blueberries, a low dose, or a high dose of freeze-dried blueberries, with commercial artificial blueberry flavoring added to maintain blinding. Adherence will be verified by recording the consumption time and through visual confirmation of the milkshake container by the independent researcher who manages the blinding. Following this, 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. All blood samples will be taken by a nurse or by researchers trained in phlebotomy.
Intervention code [1] 329258 0
Prevention
Intervention code [2] 329259 0
Early detection / Screening
Comparator / control treatment
To assess the protective effect of blueberries, the high-fat high-carbohydrate milkshake without freeze-dried blueberry will serve as the comparator.
Control group
Active

Outcomes
Primary outcome [1] 339085 0
Superoxide dismutase 1 protein levels in plasma
Timepoint [1] 339085 0
Postprandial time course study with measurements taken at -120 min, -60 min, 0 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min. There is no one time point that is the primary time point.
Secondary outcome [1] 438495 0
Plasma glucose levels
Timepoint [1] 438495 0
Postprandial time course study with measurements taken at -60 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Secondary outcome [2] 438496 0
Plasma insulin levels
Timepoint [2] 438496 0
Postprandial time course study with measurements taken at -60 min, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min.
Secondary outcome [3] 438497 0
Myeloperoxidase protein levels in plasma
Timepoint [3] 438497 0
Postprandial time course study with measurements taken at -120 min, -60 min, 0 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min.
Secondary outcome [4] 438498 0
Triglyceride levels in plasma
Timepoint [4] 438498 0
Postprandial time course study with measurements taken at -120 min, -60 min, 0 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min.
Secondary outcome [5] 438499 0
Metabolomic profiles in plasma
Timepoint [5] 438499 0
Postprandial time course study with measurements taken at -120 min, -60 min, 0 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min.
Secondary outcome [6] 438500 0
Superoxide dismutase acitivty in erythrocytes
Timepoint [6] 438500 0
Postprandial time course study with measurements taken at -120 min, -60 min, 0 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min.
Secondary outcome [7] 438563 0
Peripheral Blood Mononuclear Cells (PBMCs) Transcriptomics
Timepoint [7] 438563 0
Postprandial time course study with measurements taken at -120 min, 0 min, 120 min, 240 min, 360 min.

Eligibility
Key inclusion criteria
Adult men aged between 18 and 35 years
Body mass index between the range of 18.5 to 29.9 kg/m2
Non smoker and non vaper
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Body mass index outside the range of 18.5 to 29.9 kg/m2
- Aged less than 18 or greater than 35 years
- Smoker and vaper
- Currently have chronic medical condition, such as gstrointestinal disease or autoimmune disease
- Receiving regular medication
- Dietary allergies or restrictions that prevent consuming the meals, i.e. lactose intolerant or allergies to the milkshake ingredients (milk, blueberries)

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 in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by drawing sequence from a hat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Statistical methods / analysis
12 participants are required to show a 20% change in superoxide dismutase 1 protein levels, a biomarker of oxidative stress. 15 participants will be recruited to allow for up to 25% dropout rate.

Statistical analysis will be performed using the SPSS Statistics software. A repeated ANOVA will be conducted to determine differences in superoxide dismutase 1 protein levels between treatments. The same analysis will be applied to secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317168 0
University
Name [1] 317168 0
Monash University
Country [1] 317168 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319431 0
None
Name [1] 319431 0
Address [1] 319431 0
Country [1] 319431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315912 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315912 0
Ethics committee country [1] 315912 0
Australia
Date submitted for ethics approval [1] 315912 0
11/07/2024
Approval date [1] 315912 0
31/07/2024
Ethics approval number [1] 315912 0
42966

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

Contacts
Principal investigator
Name 136194 0
Dr Aimee Dordevic
Address 136194 0
Monash University, Be Active Sleep Eat (BASE) Facility, Level 1, 264 Ferntree Gully Road, Notting Hill 3168 VIC
Country 136194 0
Australia
Phone 136194 0
+61 399024270
Fax 136194 0
Email 136194 0
[email protected]
Contact person for public queries
Name 136195 0
Rafika Eviana
Address 136195 0
Monash University, Be Active Sleep Eat (BASE) Facility, Level 1, 264 Ferntree Gully Road, Notting Hill 3168 VIC
Country 136195 0
Australia
Phone 136195 0
+61 399024270
Fax 136195 0
Email 136195 0
[email protected]
Contact person for scientific queries
Name 136196 0
Rafika Eviana
Address 136196 0
Monash University, Be Active Sleep Eat (BASE) Facility, Level 1, 264 Ferntree Gully Road, Notting Hill 3168 VIC
Country 136196 0
Australia
Phone 136196 0
+61 399024270
Fax 136196 0
Email 136196 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


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.