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Trial registered on ANZCTR


Registration number
ACTRN12619000929101
Ethics application status
Approved
Date submitted
19/06/2019
Date registered
3/07/2019
Date last updated
12/02/2021
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing oxidative stress caused by a meal in healthy males
Scientific title
Assessing a time course of plasma myeloperoxidase, a marker of oxidative stress, following a high fat high carbohydrate meal in healthy males
Secondary ID [1] 298536 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 313351 0
Condition category
Condition code
Metabolic and Endocrine 311789 311789 0 0
Metabolic disorders
Diet and Nutrition 311894 311894 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single arm intervention study. The study requires healthy male participants to make two visits to the testing facility.

The first visit is a screening visit where eligible participants will also have their height, weight, waist circumference and body composition measured by a researcher trained in collecting anthropometric measures. At this visit participants will also provide the research team with basic demographic information (age, sex, ethnicity).

The second visit, designated as the testing visit, has participants attending the testing facility from 8:00 am to 5:00 pm. Participants will arrive to this visit following an overnight fast after consuming a standardised dinner meal the night before (participants are provided with a pre-prepared meal, which is to be re-heated in the microwave), between 7:00 and 9:00 pm. Participants will also be asked to avoid a list of foods high in antioxidants and avoid strenuous exercise for the 24 hours prior to 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 testing visit, the participants will have a cannula inserted into a vein in their arm by a nurse, for multiple blood draws. Participants will also have capillary blood samples taken during the testing visit, via finger pricks. Following a two hour run-in period, including venous and capillary blood sampling, participants are given a high fat high carbohydrate challenge meal (48% carbohydrates, 39% fat; smoothie containing ~50% of daily estimated energy requirements based on participant weight) to consume within 10 minutes (time 0). 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. Finger prick blood samples will be collected 30 and 60 minutes following the meal. All blood samples will be taken by a nurse or by researchers trained in phlebotomy.

During the testing visit participants will also be asked to complete a series of questionnaires about the food intake and physical activity. With the guidance of the researchers, participants will complete a food frequency questionnaire with a focus on high antioxidant foods, a 24-hour food recall to asses their usual intake and compliance with consuming the standardised dinner meal, and the International Physical Activity Questionnaire (IPAQ) to assess their participation in walking, moderate and vigorous physical activity.
Intervention code [1] 314868 0
Prevention
Intervention code [2] 314869 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320467 0
Myeloperoxidase enzyme activity in serum as assessed by colorimetric assay
Timepoint [1] 320467 0
Postprandial time course study with measurements taken -2 hours, -1 hour, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min before/after the meal. There is no one time point that is the primary time point.
Secondary outcome [1] 371715 0
Plasma glucose concentration as assessed by Thermo Fisher Indiko clinical chemistry analyser
Timepoint [1] 371715 0
Postprandial time course study with measurements taken -2 hours, -1 hour, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min and 360 min before/after the meal. There is no one time point that is the primary time point.
Secondary outcome [2] 371716 0
White blood cell count as assessed by HemoCue WBC DIFF analyser using finger prick capillary blood samples
Timepoint [2] 371716 0
-1 hour, 30 min and 60 min before/after the meal. There is no one time point that is the primary time point.
Secondary outcome [3] 372005 0
Usual dietary intake (energy intake and macronutrient composition) as assessed using a 24-hour food recall questionnaire
Timepoint [3] 372005 0
Recall completed on the testing day recalling all food consumed in the prior 24 hours.
Secondary outcome [4] 372006 0
Usual polyphenol intake as assessed using an updated version of a validated food frequency questionnaire designed for assessing intake of high polyphenol foods
Timepoint [4] 372006 0
Completed on testing day and assessing intake from the previous month.
Secondary outcome [5] 372007 0
Usual physical activity level (MET score) as assessed using the International Physical Activity Questionnaire (IAPQ) short version
Timepoint [5] 372007 0
Completed on the testing day and assessing physical activity from the previous week

Eligibility
Key inclusion criteria
• Body mass index between the range of 18.5 to 25.0 kg/m2
• Blood pressure between 90/60 and 140/90 mmHg
• Aged between 18 and 35 years
• Non-smoker
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 25.0 kg/m2
• Blood pressure below 90/60 or above 140/90 mmHg
• Taking medications with antioxidant activity or that may affect absorption of phytochemicals
• Taking nutritional supplements with antioxidant activity
• Diagnosed with a medical condition
• Consume greater than 14 standard drinks of alcohol per week
• Has an implanted cardiac defibrillator
• Has any dietary allergies/intolerances that prevent consuming study meals

Study design
Purpose of the study
Diagnosis
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)
Not applicable
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
15 participants are required to show a 20% change in myeloperoxidase (MPO), a biomarker of oxidative stress. 20 participants will be recruited to allow for up to a 25% dropout rate.

Statistical analysis will be carried out using SPSS Statistics software package. Data will be assessed using descriptive statistics to identify the time points at which myeloperoxidase activity is first detected and at which it reaches peak activity. Similar analysis will be used for secondary outcomes of plasma glucose concentration and capillary white blood cell count.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Participant recruitment was ceased due to COVID-19.
Date of first participant enrolment
Anticipated
22/07/2019
Actual
3/09/2019
Date of last participant enrolment
Anticipated
28/08/2019
Actual
6/11/2019
Date of last data collection
Anticipated
11/09/2019
Actual
27/11/2019
Sample size
Target
20
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26801 0
3168 - Notting Hill
Recruitment postcode(s) [2] 26802 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 303079 0
University
Name [1] 303079 0
Monash University
Country [1] 303079 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Clayton Campus,
Wellington Road, Clayton 3800
VIC
Country
Australia
Secondary sponsor category [1] 303065 0
None
Name [1] 303065 0
None
Address [1] 303065 0
None
Country [1] 303065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303627 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 303627 0
Ethics committee country [1] 303627 0
Australia
Date submitted for ethics approval [1] 303627 0
18/04/2019
Approval date [1] 303627 0
17/05/2019
Ethics approval number [1] 303627 0
2019-18917-32133

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

Contacts
Principal investigator
Name 94314 0
Dr Aimee Dordevic
Address 94314 0
Monash University, Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road
Notting Hill 3168 VIC
Country 94314 0
Australia
Phone 94314 0
+61 3 9905 2142
Fax 94314 0
Email 94314 0
aimee.dordevic@monash.edu
Contact person for public queries
Name 94315 0
Margaret Murray
Address 94315 0
Room 218, 13 Rainforest Walk
Monash University Clayton Campus,
Clayton 3800 VIC
Country 94315 0
Australia
Phone 94315 0
+61 3 9905 1415
Fax 94315 0
Email 94315 0
margaret.murray@monash.edu
Contact person for scientific queries
Name 94316 0
Margaret Murray
Address 94316 0
Room 218, 13 Rainforest Walk
Monash University Clayton Campus,
Clayton 3800 VIC
Country 94316 0
Australia
Phone 94316 0
+61 3 9905 1415
Fax 94316 0
Email 94316 0
margaret.murray@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This form of data sharing was not included in the ethics application.


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.