Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000231549
Ethics application status
Approved
Date submitted
1/06/2023
Date registered
7/03/2024
Date last updated
7/03/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The short-term effect of breads consumption on serum glucose level.
Scientific title
The short-term effect of bread consumption on serum glucose level among UiTM Puncak Alam students: A randomized controlled trial
Secondary ID [1] 309814 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus 330230 0
Condition category
Condition code
Metabolic and Endocrine 327102 327102 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The data will collect from residential college of Universiti Teknologi Mara (UiTM) Puncak Alam which the candidates are among undergraduate student students from various programmes which are Health Sciences, Pharmacy, Accountancy, Education, Business and Management, Hotel and Tourism Management. The candidate must fulfil the inclusion and exclusion criteria before selected to be the sample of this research. The brief explanation given to the respondents by the researcher before they allow to fill the form. The researcher will explain to them regarding the information sheets, the procedure guidelines, consent form, the objective of this study and the duration of the procedure. The data are collected from the participants socio-demographic such as gender, age, and family history will be collected using information sheets before the intervention conduct. The information sheets consist of title, objectives, procedures, and confidentially of this study. A written consent form will be given to the participant to sign if the participant has agreed to participate in this study. The consent form explained to get the official agreement before conducting the research. After participants fill up the form, all the data collected will keep confidentially by keeping the participants’ names anonymously.

A day before the procedure, the participants need to fast 8 to 10 hours prior to experiment and not allow to drink or eat within the time given. The next day, before the procedure start, participants will need to do anthropometry which they need to weigh using weigh scale and measure height. Later, the researcher will calculate their Body Mass Index (BMI) to ensure the participants weight within normal range 18.4 to 24.9 kg/m² as stated in inclusion criteria to be part of the study. Those participants do not meet with BMI requirements will be excluded from this study. Next, participants need to take blood glucose level using glucometer for pre-prandial glucose reading as a baseline. Later, participants need to pick a paper that may label as A or B inside the box. The participants will be divided equally into two groups which are control group and intervention groups. The participants be in a group label as A and B and the breads will be distributed according to their labels. The researcher and participants will not know types of breads wrapped in A or B (double blinded). The breads will be packed by breads company X that will provide the packaging for the breads. Only the breads supplier will know the packaging A and B consists of which types of breads. The participants will be provided either whole grain breads or white breads. Intervention group is the low GI bread which refers to bread that has a lower impact on blood sugar levels compared to high-GI bread. Low GI made from wholegrain. Low GI bread refer as bread made using at least 80% of whole grains.


Participants are not allowed to drink water within 2 hours after consuming breads. Within 2 hours after eating the breads, post-prandial blood sugar reading will be taken. The results obtained will be collected and filled in the form. Participants will be expected to eat 2 slices (100g) of bread with no topping.
Intervention code [1] 326248 0
Treatment: Other
Comparator / control treatment
Control group (White bread): Bread with high glycemic index (GI).
High GI refer as bread made using at least 80% white wheat flour.
Control group
Active

Outcomes
Primary outcome [1] 334963 0
Primary outcome 1: change of blood glucose level using glucometer.
Timepoint [1] 334963 0
Timepoint: 2 hours after intervention.
Secondary outcome [1] 422559 0
NIL
Timepoint [1] 422559 0
NIL

Eligibility
Key inclusion criteria
The inclusion criteria:
• Age: 18 to 24 years old.
• Gender: Females and males.
• Courses: Health Sciences, Education, Accountancy, Pharmacy, Business and Management, Hotel Tourism Management.
• Free from Type-1 Diabetes Mellitus (T1DM), Type-2 Diabetes Mellitus (T2DM) , hypertension, overweight.
• BMI: within normal ranges 18.5 to 24.9 kg/m².
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria:

-Pregnant lady.
-Breastfeeding mother.
-Presence of chronic condition such as asthma, Diabetes Mellitus and Hypertension

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 opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like pick 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 29.0 will be used for data entering and analysing.

Sample size calculation.
The Sakpal formula (2010) will be used to calculate the required sample size:
Calculation of comparing two means.
Consider the drop out of 10% . Level of significance = 5%, Power = 80%, Type of test =two-sided.

where:
n = sample size required in each group,
µ1 = mean of post-prandial glucose level of white bread (control group).
µ2 = mean of post-prandial glucose level of wholegrain bread (intervention group).
µ1-µ2 = clinically significant difference = 0.5
ó = standard deviation = 33.2
Z a/2: This depends on level of significance = 1.96
Zß: This depends on power = 80% 0.84
Calculation based on previous study:

n= (1.96+0.84) ² x (2 ( 33.2 ) ² / (159.50 – 123.73) ²
n = (2.8) ²x (2204.48) / (35.77)²
n = 13. 50 (13 participants each group).
Since the sample is too small, therefore the popular rule of thumb will be used which sample size n= 30 for each group, control and intervention group. The total number of participants involves in this study n=60

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2023
Date of last participant enrolment
Anticipated
Actual
29/12/2023
Date of last data collection
Anticipated
Actual
7/01/2024
Sample size
Target
60
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 25572 0
Malaysia
State/province [1] 25572 0
Selangor

Funding & Sponsors
Funding source category [1] 314000 0
Commercial sector/Industry
Name [1] 314000 0
NOVA LABORATORIES SDN. BHD
Country [1] 314000 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] 315884 0
None
Name [1] 315884 0
Address [1] 315884 0
Country [1] 315884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313138 0
Research and Ethics Committee of Universiti Teknologi Mara (UiTM)
Ethics committee address [1] 313138 0
Ethics committee country [1] 313138 0
Malaysia
Date submitted for ethics approval [1] 313138 0
04/07/2023
Approval date [1] 313138 0
04/08/2023
Ethics approval number [1] 313138 0

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

Contacts
Principal investigator
Name 127118 0
Dr DR SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127118 0
Universiti Teknologi MARA Cawangan SelangorCentre for Nursing Studies,Kampus Puncak Alam, 42300 Bandar Puncak Alam,Selangor, Malaysia
Country 127118 0
Malaysia
Phone 127118 0
+60132851116
Fax 127118 0
Email 127118 0
[email protected]
Contact person for public queries
Name 127119 0
DR SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127119 0
Universiti Teknologi MARA Cawangan SelangorCentre for Nursing studiesKampus Puncak Alam, 42300 Bandar Puncak Alam,Selangor, Malaysia
Country 127119 0
Malaysia
Phone 127119 0
+60132851116
Fax 127119 0
Email 127119 0
[email protected]
Contact person for scientific queries
Name 127120 0
DR SHARIFAH SHAFINAZ BINTI SH ABDULLAH
Address 127120 0
Universiti Teknologi MARA Cawangan SelangorCentre of Nursing studies,Kampus Puncak Alam, 42300 Bandar Puncak Alam,Selangor, Malaysia
Country 127120 0
Malaysia
Phone 127120 0
+60132851116
Fax 127120 0
Email 127120 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.