The effects of bread containing Fenugreek and Cinnamon on anthropometric indices, glycemic status and lipid profile in patients with type 2 diabetes mellitus
Determining the effect toast contains fenugreek and cinnamon on glucose control in patients with diabetes
Design
Randomized controlled clinical trial with a parallel group Phase 2 of 100 patients. Which the random function of Excel software was used for randomization.
Settings and conduct
Eligible patients will be selected by the announcement and reffering by physicians among those referred to Diabetic clinics affiliated to Tehran University of Medical Sciences. Before starting the trial, the study will be explained to eligible individuals and if they have the tendency to participate, they will sign the written informed consent. Due to the type of intervention in this study, complete blindness is not possible. However, a colleague who will analysis data is not aware of the groups. Finally, encoded data will be provided to the data analysis team.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients with type 2 diabetes mellitus
taking oral anti-diabetic medications
Age 30 to 70 years
Lack of liver and kidney disease, uncontrolled thyroid and other complications of diabetes leading to inflammatory and oxidative conditions, other types of diabetes
Not pregnant or breastfeeding
Intervention groups
The first group :toast contains fenugreek and cinnamon
The second group :placebo toast (containing wheat flour)
The third group : common breads
Main outcome variables
Fasting blood sugar, glycosylated hemoglobin and anthropometric indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110314006065N4
Registration date:2022-02-21, 1400/12/02
Registration timing:registered_while_recruiting
Last update:2022-02-21, 1400/12/02
Update count:0
Registration date
2022-02-21, 1400/12/02
Registrant information
Name
Nazli Namazi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 9630
Email address
nazli.namazi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-23, 1400/10/02
Expected recruitment end date
2022-04-10, 1401/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of bread containing Fenugreek and Cinnamon on anthropometric indices, glycemic status and lipid profile in patients with type 2 diabetes mellitus
Public title
The effects of bread containing Fenugreek on health of patients with type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes (fasting blood sugar less than or equal to 126 Milligrams in deciliter and two-hour blood sugar greater than or equal to 200 Milligrams in deciliter)
Receiving blood sugar lowering drugs
HbA1c more than 10%
Body mass index less than 40 kilogram in square meter
Exclusion criteria:
Insulin or liraglutide injection
Type 1 diabetes
History of chronic liver and kidney disease, diabetic foot ulcer, various malignancies, rheumatic and infectious diseases
• Take any herbal medicine or herbal medicine to control blood sugar at present History of any allergies to herbs
Pregnant or lactating women
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided (six random blocks) into three groups of 30. One group eats toast containing fenugreek and cinnamon, the second group eats placebo toast (containing wheat flour) and the third group eats common breads. Randomization is done using an online system (https://www.sealedenvelope.com/). After randomization, each patient is given a code that is identified during the study. The random number is assigned sequentially. Randomization is not visible to those conducting the study and is provided in matte and sealed envelopes with consecutive numbers. The envelope is opened after patients sign the informed consent form and meet the eligibility criteria.
Blinding (investigator's opinion)
Double blinded
Blinding description
Envelopes containing fortified bread and not fortified toast will be exactly the same in shape, color and size of packaging and will be stored in dark packaging. The packages will be named A and B, and the researcher does not know which bread each group uses.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Endocrinology & Metabolism Research Institute
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.TUMS.EMRI.REC.1400.041
Health conditions studied
1
Description of health condition studied
Type 2 diebetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
Secondary outcomes
1
Description
HbA1c
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
En Chromatography
2
Description
weight
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Scales
3
Description
Total cholesterol
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
Intervention groups
1
Description
Intervention group: Group consumes a toast containing fenugreek and cinnamon. Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily.
Category
Treatment - Other
2
Description
Intervention group: The second group consumes placebo toast (containing wheat flour). Baked bread will replace 4 units of common bread and the study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily.
Category
Treatment - Other
3
Description
Control group: Control group: Consume common breads. .study will continue for 8 weeks. Carbohydrates will be considered for all three study groups, taking into account 55% of carbohydrates consumed daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Institute
Full name of responsible person
Nazli Namazi
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
nazli.namazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotuhi
Street address
Vice Chancellor of Research and Technology Tehran University of Medical Sciences, Ghods Street, Keshavarz Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
nazli.namazi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available