Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000345482
Ethics application status
Approved
Date submitted
18/12/2024
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of ethnicity on Meal Induced Thermogenesis (MIT study)
Scientific title
The effect of ethnicity on Meal Induced Thermogenesis (MIT) in adults with Asian or Caucasian ethnicity
Secondary ID [1] 313493 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 335903 0
Visceral adiposity 335904 0
Condition category
Condition code
Diet and Nutrition 332500 332500 0 0
Other diet and nutrition disorders
Diet and Nutrition 332499 332499 0 0
Obesity
Metabolic and Endocrine 332501 332501 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The standard breakfast meal consists of a muesli bar, chocolate breakfast drink, and a bowl of oats (2524kJ, 55% carbohydrates, 13.2% protein, 27.5% fat). Participants will have 15mins to consume the breakfast meal and adherence is assessed using direct observation.

The outcome observed is energy expenditure above resting metabolic rate (i.e. meal induced thermogenesis) for four hours after the standard breakfast meal in people of Asian ethnicity compared with people of Caucasian ethnicity. The resting metabolic rate and meal induced thermogenesis of the participant will be measured using indirect calorimetry by an experienced researcher.
Intervention code [1] 330067 0
Lifestyle
Comparator / control treatment
People of Caucasian ethnicity (aged 18-40 years)
Control group
Active

Outcomes
Primary outcome [1] 340026 0
Meal induced thermogenesis assessed using indirect calorimetry
Timepoint [1] 340026 0
Baseline, 1h,2h,3h,4h after the breakfast meal
Secondary outcome [1] 442362 0
Resting metabolic rate assessed using indirect calorimetry
Timepoint [1] 442362 0
Baseline (before breakfast)
Secondary outcome [2] 443173 0
Subjective appetite indices (e.g. hunger, fullness, desire to eat) assessed using a 100mm Visual Analogue Scale (VAS)
Timepoint [2] 443173 0
Baseline (before breakfast), then 15mins, 30mins, 1hr, 2h, 3h and 4h after the meal
Secondary outcome [3] 443174 0
Food intake assessed by a 3 day food diary.
Timepoint [3] 443174 0
At baseline, participant to complete (2 weekdays and 1 weekend day) and bring to the visit.
Secondary outcome [4] 443176 0
Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
Timepoint [4] 443176 0
Within the 4 hours post breakfast during the study and before participants went home. The questionnaire refers to physical activity in the last 7 days, so it did not matter when during the 4 hours the questionnaire was completed.
Secondary outcome [5] 443177 0
Eating behaviour assessed by the Dutch Eating Behaviour Questionnaire (DEBQ)
Timepoint [5] 443177 0
Within the 4 hours post breakfast during the study and before participants went home. Similar to the IPAQ, this questionnaire was not timepoint dependent.

Eligibility
Key inclusion criteria
• Aged 18-40 years old
• Asian or Caucasian ethnicity
• Healthy weight BMI 18.5kg/m2 - 23kg/m2 if you are Asian; or
BMI 18.5kg/m2 – 24.9kg/m2 if you are Caucasian
• Weight stable (within +/-2kg in the last 6 months)
• Non-smoker and not vaping
• Not pregnant or breastfeeding
• Not on any medications known to alter body composition or metabolism (e.g. thyroxin, insulin, antidepressants, glucocorticoids)
• Not have any food allergies or intolerances (e.g. lactose, gluten)
• Not diagnosed with, and not on drug therapy for diabetes, high blood pressure, high cholesterol or cardiovascular disease
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size calculation was not done, as this exploratory study is the first to address this specific research question, The sample size of n= 12 in each ethnic group, was chosen to estimate the statistical parameter values for future sample size calculations. The number was based on recommendations from the literature regarding pilot studies.
T-test or non parametric alternative will be used to compare outcomes between groups. Time course analysis of outcomes (MIT and appetite) will be assessed using a mixed ANOVA to determine group effect, time effect and group x time interactions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/07/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
24
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318047 0
University
Name [1] 318047 0
Monash University, Department of Nutrition, Dietetics and Food
Country [1] 318047 0
Australia
Primary sponsor type
University
Name
Monash University, Department of Nutrition, Dietetics and Food
Address
Country
Australia
Secondary sponsor category [1] 320399 0
None
Name [1] 320399 0
Address [1] 320399 0
Country [1] 320399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316702 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 316702 0
Ethics committee country [1] 316702 0
Australia
Date submitted for ethics approval [1] 316702 0
19/06/2024
Approval date [1] 316702 0
01/07/2024
Ethics approval number [1] 316702 0
43756

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

Contacts
Principal investigator
Name 47898 0
Dr Kay Nguo
Address 47898 0
Monash University Department of Nutrition, Dietetics and Food. Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 47898 0
Australia
Phone 47898 0
+6139905 5357
Fax 47898 0
Email 47898 0
[email protected]
Contact person for public queries
Name 47899 0
Kay Nguo
Address 47899 0
Monash University Department of Nutrition, Dietetics and Food. Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 47899 0
Australia
Phone 47899 0
+6139905 5357
Fax 47899 0
Email 47899 0
[email protected]
Contact person for scientific queries
Name 47900 0
Kay Nguo
Address 47900 0
Monash University Department of Nutrition, Dietetics and Food. Level 1, 264 Ferntree Gully Road, Notting Hill VIC 3168
Country 47900 0
Australia
Phone 47900 0
+6139905 5357
Fax 47900 0
Email 47900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
Following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Via a data repository (a proposed repository is the IAEA) and available only to achieve the aims in an approved proposal. Any shared data will remain anonymous and there will be no way that participants can be identified.

• Email of trial custodian, sponsor or committee: Principal investigator- [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.