The effect of bread containing cumin on blood sugar in type 2 diabetic patients
Design
A trial with a control group, with parallel, double-blind, randomized groups, is performed on 60 type 2 diabetes patients. randomization method is Stratified Intervention group: Bread cumin
cumin Control group: Placebo bread
Settings and conduct
The study will be conducted at the Yazd Diabetes Research Center. 60 type 2 diabetic patients with medical records and being treated with oral drugs with inclusion criteria will be included in the study. Then the volunteers are randomly stratified (based on age, gender and average HbA1c) divided into two equal intervention and control groups. In the intervention group, daily amount of 120 grams of new formula bread (cumin bread) is given for consumption by all family members for 2 months and it is recommended to include said bread as part of their three meals. It is also recommended that they do not change their usual diet and physical activity level during the study period. In the control group, bread without cumin (of the same quality) is given. At the beginning and end of the study, weight, height, HbA1c and blood lipid profile (T.G, CHOL, both experimental groups) will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Type 2 diabetes patients with HbA1c<9
2) Male and female between 30 years old and older living in Yazd
3) Absence of chronic systemic diseases (liver, kidney, Neurological and psychiatric diseases)
Exclusion criteria:
1) Drug and alcohol addiction
2) Special diets
3) Participation in special sports programs (championship sports)
4) Insulin use
5) Creatinine higher than 1.2
6) Medical reasons (chronic systemic diseases and mental-psychological diseases)
7) Pregnancy or breastfeeding
Intervention groups
Intervention group: Bread cumin
Control group: Placebo bread
Main outcome variables
HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160221026684N4
Registration date:2022-12-31, 1401/10/10
Registration timing:prospective
Last update:2022-12-31, 1401/10/10
Update count:1
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Seyed Ali Khodaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0215
Email address
sa.khodaei@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bread containing cumin on blood sugar in type 2 diabetic patients
Public title
The effect of cumin bread on blood sugar in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes
HbA1c<9
At least 30 years old
A resident of Yazd
Absence of chronic systemic diseases
Exclusion criteria:
Drug and alcohol addiction
Special diets
Special sports programs
Taking insulin
Creatinine above 1.2
Pregnancy or breastfeeding
Medical reasons (Chronic systemic diseases and mental-psychological diseases)
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 patients with type 2 diabetes and meeting the inclusion criteria will be selected. After determining all available samples, stratified random allocation will be done in three layers of age, gender and average HbA1c. First, all patients are divided into two groups based on gender, and from both groups, an equal number of women will be placed in both the intervention and control groups, and an equal number of men will be placed in the intervention and control groups.
In the next step, all the patients who are assigned to two groups in terms of gender will be divided into four groups in terms of age and will be placed again in the intervention and control groups.
Finally, we will have two groups of patients with similar age and gender distribution for intervention and control.
Intervention allocation or random allocation is in the form of a closed envelope that the individual chooses before entering the researcher's room. The envelope with the letter A will be the intervention group and B will be the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the main researchers are aware of the type of bread. The participating volunteers and other people involved in the project have no information about the type of bread. Both breads are similar in terms of shape, color, smell, packaging and appearance, and blinding has been done between them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid sadoughi university of medical sciences
Street address
Diabetes Research Center, Talar-e-Honar Alley, Shahid Sadoughi Blvd, Yazd
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2022-12-14, 1401/09/23
Ethics committee reference number
IR.SSU.REC.1401.068
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
HbA1c
Timepoint
At the beginning and end of the intervention (8 weeks after the start)
Method of measurement
Chromatography (HPLC)
Secondary outcomes
1
Description
Serum triglyceride level
Timepoint
At the beginning and end of the intervention (8 weeks after the start)
Method of measurement
Enzymatic method
2
Description
Serum total cholesterol level
Timepoint
At the beginning and end of the intervention (8 weeks after the start)
Method of measurement
Enzymatic method
Intervention groups
1
Description
Intervention group: Bread cumin: Bread made from whole wheat flour and cumin- Flour composition includes 96% whole wheat flour + 2% cumin powder + 2% the rest includes dough and permitted bread additives such as salt and standard ingredients to improve the quality of bread, which is turned into bulk bread in "Golnan Puratos" factory.
Category
Treatment - Other
2
Description
Control group: Placebo bread: Bread made from whole wheat flour- The flour composition includes 98% whole wheat flour + the remaining 2%, including sourdough and authorized bread additives such as salt and standard ingredients that improve the quality of bread, which is converted into bulk bread in "Golnan Puratos" factory.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Seyed Ali Khodaie
Street address
Talar-e-Hanar Alley, North Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
alireza moradi
Street address
Talar-e-Hanar Alley, North Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3628 9180
Email
alirezampr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Ali Khodaie
Position
Non-academic specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North Shahid Sadoughi BLVD
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Ali Khodaie
Position
Non-academic specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North Shahid Sadoughi blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Ali Khodaie
Position
Non-academic specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North Shahid Sadoughi blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
HbA1c data : Data on the main outcome will be made available to other researchers with the permission of the first executor
When the data will become available and for how long
Starting one year after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Coordinate with project analyzer
From where data/document is obtainable
Dr. Seyed ali Khodaie :03537280215 dr.seyedalikhodaie@yahoo.com
What processes are involved for a request to access data/document
Request data from Yazd University of Medical Sciences, approval of the director of the Diabetes Research Center, approval of the first executor of the project