Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001083684
Ethics application status
Approved
Date submitted
1/06/2023
Date registered
13/10/2023
Date last updated
13/10/2023
Date data sharing statement initially provided
13/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The short-term effects of coffee on heart rate and blood pressure
Scientific title
The short-term effects of coffee on heart rate and blood pressure in habitual consumers among lecturers in Faculty of Health Sciences UiTM Puncak Alam: A Randomised Controlled Trial (RCT) Study
Secondary ID [1] 309795 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 330231 0
Condition category
Condition code
Cardiovascular 327101 327101 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two types of coffee which are caffeinated and decaffeinated coffee will be used in this study. The recruitment of the participant will be conducted based on the inclusion and exclusion criteria. 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 coffee A whereas participants with the alphabet B received a cup of coffee B.

The researcher along with a research supervisor will conduct this procedure. Both types of coffee were prepared and provided by a local company. To maintain allocation concealment, both coffees were made to appear similar (sachet type, sachet size, sachet colour, amount of coffee, and colour of coffee). The only exception is the label (code) attached to the front of the sachet, A for coffee A and B for coffee B. This was a double-blind study where both participants and experimenters were not exposed to the code. Heart rate and blood pressure reading of participants will be taken before carrying out the experiment by using CHOICEMMED pulse oximeter and Novoplus Blood pressure monitor. Coffee will be made by the experimenter by using 200ml of hot water, caffeinated and decaffeinated coffee sachet that are provided by supervisor, and 250ml cups. Participants then drinking the coffee and any side effects will be observed. After 15minutes of consuming, heart rate reading will be taken using the same CHOICEMMED pulse oximeter. Blood pressure reading will be taken after 1 hour consuming the coffee. Researcher will collect the data until having enough participants, n=30.
Intervention code [1] 326249 0
Lifestyle
Comparator / control treatment
Control group is participant that drink decaffeinated coffee.
Control group
Active

Outcomes
Primary outcome [1] 334964 0
Blood pressure reading

tool that used to measure blood pressure is automatic blood pressure machine
Timepoint [1] 334964 0
Timepoint: 1 hour after intervention
Primary outcome [2] 334965 0
Heart rate reading

tool that used to measure heart rate reading is automatic heart rate monitor which is a pulse oximeter.
Timepoint [2] 334965 0
Timepoint: 15 minutes after intervention
Secondary outcome [1] 422560 0
Nil
Timepoint [1] 422560 0
Nil

Eligibility
Key inclusion criteria
1) Age from 28-55 years old.
2) Both female and male.
3) Free from hypertension and heart problems.
4) Free from any chronic disease
Minimum age
28 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Caffeine intolerance.
2) Pregnant women.
3) Breastfeeding mothers.

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)
sealed envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like pick between two envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM Statistical Package for Social Sciences Software (SPSS) version 27.0 will be used for data entering and analysis. Prior to data analysis as outliers were observe using box plot. Categorical data calculated using frequency and percentage. Normally distributed numerical data were described by presenting mean and standard deviation (SD). Estimation was performed by measuring their point estimations and 95% confident interval. Hypothesis testing to determine short term effects of coffee on blood pressure pre and post coffee consumption will be using paired t-test and independent t-test. Hypothesis testing using paired t-test and independent t-test also will be used to identify the short-term effects of coffee on heart rate reading pre and post coffee consumption. Last hypothesis testing using Pearson correlation to investigate the relationship between effect of caffeinated and decaffeinated coffee on heart rate and blood pressure among coffee consumers. Significant level was set at a < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2023
Actual
Date of last participant enrolment
Anticipated
10/11/2023
Actual
Date of last data collection
Anticipated
28/02/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 25571 0
Malaysia
State/province [1] 25571 0
Selangor

Funding & Sponsors
Funding source category [1] 313978 0
Commercial sector/Industry
Name [1] 313978 0
NOVA LABORATORIES SDN. BHD.
Country [1] 313978 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
NOVA LABORATORIES SDN. BHD.
Address
NOVA LABORATORIES Lot 708, Nova avenue, 4th Mile, 43950 Sungai Pelek, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 315852 0
None
Name [1] 315852 0
NONE
Address [1] 315852 0
NONE
Country [1] 315852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313116 0
Research and Ethics Committee of Universiti Teknologi Mara (UiTM)
Ethics committee address [1] 313116 0
Ethics committee country [1] 313116 0
Malaysia
Date submitted for ethics approval [1] 313116 0
04/07/2023
Approval date [1] 313116 0
04/08/2023
Ethics approval number [1] 313116 0

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

Contacts
Principal investigator
Name 127050 0
Dr SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127050 0
CENTRE FOR NURSING STUDIES, UITM CAWANGAN SELANGOR, KAMPUS PUNCAK ALAM, 42300 BANDAR PUNCAK ALAM, SELANGOR
Country 127050 0
Malaysia
Phone 127050 0
+60 132851116
Fax 127050 0
Email 127050 0
[email protected]
Contact person for public queries
Name 127051 0
SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127051 0
CENTRE FOR NURSING STUDIES, UITM CAWANGAN SELANGOR, KAMPUS PUNCAK ALAM, 42300 BANDAR PUNCAK ALAM, SELANGOR
Country 127051 0
Malaysia
Phone 127051 0
+60 132851116
Fax 127051 0
Email 127051 0
[email protected]
Contact person for scientific queries
Name 127052 0
SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127052 0
CENTRE FOR NURSING STUDIES, UITM CAWANGAN SELANGOR, KAMPUS PUNCAK ALAM, 42300 BANDAR PUNCAK ALAM, SELANGOR
Country 127052 0
Malaysia
Phone 127052 0
+60 132851116
Fax 127052 0
Email 127052 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.