Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001195640
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
17/11/2023
Date last updated
17/11/2023
Date data sharing statement initially provided
17/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Plant-Based and Animal-Based Milk: Effects on Heart Rate, Blood Pressure, and Serum Glucose Levels in UITM Puncak Alam Students
Scientific title
The Short-Term Effects Of Plant-Based Milk And Animal-Based Milk On Heart Rate, Blood Pressure And Serum Glucose Level, Their Tolerance And Side Effects Towards It Among Students In Uitm Puncak Alam: A Randomized Controlled Trial
Secondary ID [1] 310077 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy adult with lactose intolerance 330620 0
Adult with diabetes mellitus 331102 0
Adult with hypertension 331103 0
Condition category
Condition code
Diet and Nutrition 327456 327456 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomization and allocation concealment were conducted after obtaining informed consent. The participants will be randomized using block randomization (1:1). The random alphabet A and B will each be placed into an envelope. The envelopes were then distributed to the participants on a first come first serve basis during recruitment. Participants with the alphabet A received a cup of milk A whereas participants with the alphabet B received a cup of milk B.

The researcher along with a research supervisor (a certified registered nurse) will conduct this procedure. Both types of milk were prepared and provided by a local company. To maintain allocation concealment, both milk were made to appear similar (bottle type, bottle size, bottle colour, amount of milk, and colour of milk). The only exception is the label (code) attached to the bottom of the bottles, A for milk A and B for milk B. This was a double-blind study where both participants and experimenters were not exposed to the code.

Number of times the intervention will be delivered is one time and over 30 minutes in one session. The location where the interventions occurs is university laboratory room.

In this study, the origin of the plant-based milk will be soy milk and the amount of milk provided is 200 mL. This experimential will take place at the study clinic. Participants are asked to finish drinking in 15 minutes and the whole experiment takes around 2 hours per participant for serum glucose monitoring.
Intervention code [1] 326480 0
Treatment: Other
Comparator / control treatment
The control treatment will received 200ml of animal-based milk (cow milk)
Control group
Active

Outcomes
Primary outcome [1] 335731 0
Participants serum glucose level will be measured using Accu-Chek | Blood Glucose Monitor
Timepoint [1] 335731 0
Baseline pre and post interventions (after 2 hours)
Primary outcome [2] 335732 0
Participants heart rate will be measured using OMRON blood pressure monitor.
Timepoint [2] 335732 0
Baseline pre and post interventions (after 2 hours)
Secondary outcome [1] 425377 0
Participants blood pressure will be measured using OMRON blood pressure monitor.
Timepoint [1] 425377 0
Baseline pre and post interventions (after 2 hours)

Eligibility
Key inclusion criteria
Local & undergraduate health sciences student
Understand basic Malay and English languages
Minimum age
18 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Expatriate & postgraduate student
Diagnosed with heart disease, HPT, DMT1 and DMT2
Pregnant and breastfeeding
Allergy to dairy or any nuts, lactose intolerance and vegetarian

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random alphabet A and B will each be placed into an envelope. The envelopes were then distributed to the participants on a first come first serve basis during recruitment. Participants with the alphabet A received a cup of milk A whereas participants with the alphabet B received a cup of milk B.

The researcher along with a research supervisor will conduct this procedure. Both types of milk were prepared and provided by a local company. To maintain allocation concealment, both milk were made to appear similar (bottle type, bottle size, bottle colour, amount of milk, and colour of milk). The only exception is the label (code) attached to the bottom of the bottles, A for milk A and B for milk B. This was a double-blind study where both participants and experimenters were not exposed to the code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization and allocation concealment were conducted after obtaining informed consent. The participants will be randomized using block randomization (1:1).
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Number of participants needed to achieve study objectives is 60,
The sample size will be 60. Therefore, the total sample size is 30 in each group.

The data were statistically analysed using the IBM Statistical Package for Social Sciences (SPSS) version 22. After the experiment is done and data had been collected, the data will be tabulated and entered into the SPSS. The type of compare means that will be used are paired T-test and independent T-test to compare independent variables (blood pressure, heart rate and serum glucose level). Descriptive statistics will be used to analyse data of tolerancy level and the side effect of both milks. The results of the research findings are reported in statistical format and the collected data will be exported to an Excel spreadsheet for data cleaning and analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
8/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25626 0
Malaysia
State/province [1] 25626 0

Funding & Sponsors
Funding source category [1] 314243 0
Commercial sector/Industry
Name [1] 314243 0
NOVA Laboratary Sdn Bhd
Country [1] 314243 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
NOVA Laboratary Sdn Bhd
Address
Lot 708, Nova avenue, 4th Mile, 43950 Sungai Pelek, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 316528 0
None
Name [1] 316528 0
None
Address [1] 316528 0
None
Country [1] 316528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313361 0
UiTM Research Ethic Committee
Ethics committee address [1] 313361 0
Ethics committee country [1] 313361 0
Malaysia
Date submitted for ethics approval [1] 313361 0
04/07/2023
Approval date [1] 313361 0
31/07/2023
Ethics approval number [1] 313361 0

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

Contacts
Principal investigator
Name 127882 0
Dr SHARIFAH SHAFINAZ BINTI SHARIF ABDULLAH
Address 127882 0
Centre for Nursing Study, FSK, Selangor Campus UiTM Puncak Alam 42300
Country 127882 0
Malaysia
Phone 127882 0
+60 03 01111212304
Fax 127882 0
Email 127882 0
[email protected]
Contact person for public queries
Name 127883 0
SHARIFAH SHAFINAZ BINTI SHARIF ABDULLAH
Address 127883 0
Centre for Nursing Study, FSK, Selangor Campus UiTM Puncak Alam 42300
Country 127883 0
Malaysia
Phone 127883 0
+60 03 01111212304
Fax 127883 0
Email 127883 0
[email protected]
Contact person for scientific queries
Name 127884 0
TS. DR. SHARIFAH SHAFINAZ SHARIF ABDULLAH
Address 127884 0
Centre for Nursing Study, FSK, Selangor Campus UiTM Puncak Alam 42300
Country 127884 0
Malaysia
Phone 127884 0
+60 03 0332584348
Fax 127884 0
Email 127884 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
Data is only for the researcher to make the analysis and no need to be shared to others for no reason


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.