Protocol summary
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Study aim
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The effect of bread containing cumin on blood sugar in type 2 diabetic patients
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: Bread cumin
Control group: Placebo bread
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Main outcome variables
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HbA1c
General information
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Reason for update
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Change of financial support source; Due to the high costs, financial problems of Shahid Sadoughi Yazd University of Medical Sciences, and the failure to provide timely funding for the project, financial support from the private sector was used.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160221026684N4
Registration date:
2022-12-31, 1401/10/10
Registration timing:
prospective
Last update:
2025-08-09, 1404/05/18
Update count:
1
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Registration date
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2022-12-31, 1401/10/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-10, 1401/10/20
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Expected recruitment end date
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2023-08-22, 1402/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of bread containing cumin on blood sugar in type 2 diabetic patients
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Public title
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The effect of cumin bread on blood sugar in type 2 diabetic patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 30 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-12-14, 1401/09/23
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Ethics committee reference number
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IR.SSU.REC.1401.068
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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HbA1c
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Timepoint
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At the beginning and end of the intervention (8 weeks after the start)
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Method of measurement
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Chromatography (HPLC)
Secondary outcomes
1
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Description
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Serum triglyceride level
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Timepoint
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At the beginning and end of the intervention (8 weeks after the start)
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Method of measurement
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Enzymatic method
2
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Description
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Serum total cholesterol level
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Timepoint
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At the beginning and end of the intervention (8 weeks after the start)
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Method of measurement
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Enzymatic method
Intervention groups
1
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Description
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In the intervention group, it is recommended that the bread consumed by the diabetic patient should be cumin bread in all three meals and consume a total of 120 grams of cumin bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants not to change their usual diet and physical activity level during the study period. Cumin bread: Bread made from wheat flour and cumin - the flour composition includes 96% wheat flour (with commercial name of Setareh) + 2% cumin powder + the remaining 2% includes yeast and permitted bread additives such as salt and standard ingredients that improve the quality of bread, which is converted into voluminous bread in the "Golnan Poratus" factory located in Karaj.
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Category
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Treatment - Other
2
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Description
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In the control group, it is recommended that the bread consumed by the diabetic patient be ordinary regular bread in all three meals and consume a total of 120 grams of this type of bread daily for 2 months (8 weeks). The bread consumed is delivered to the patient weekly. It was also emphasized to the study participants that they should not change their usual diet and physical activity level during the study period. ordinary bread: made from wheat flour - the flour composition includes 98% wheat flour (with commercial name of Setareh) + the remaining 2% includes yeast and permitted bread additives such as salt and standard raw materials that improve the quality of the bread, which is converted into thick bread in the "Golnan Poratus" factory located in Karaj.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Behdane Baran Salem Abi
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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HbA1c data : Data on the main outcome will be made available to other researchers with the permission of the first executor
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When the data will become available and for how long
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Starting one year after publication
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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Coordinate with project analyzer
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From where data/document is obtainable
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Dr. Seyed ali Khodaie :03537280215 dr.seyedalikhodaie@yahoo.com
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What processes are involved for a request to access data/document
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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
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Comments
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