Evaluation of satiety index of cumin-based bread in healthy individuals
Design
Clinical trial, crossover, controlled
Settings and conduct
The study is conducted at Yazd Diabetes Research Center. The study will be conducted on 2 separate days, one week apart. First, people are randomly divided into two equal groups. On the first day, the first group ate 90 grams of white bread and the second group ate 90 grams of bread designed based on the formulation of a mixture of whole wheat flour and 2% cumin powder (bread containing cumin) along with a glass containing 220 ml of water. On the second day, the first group will receive 90 grams of cumin-containing bread and the second group will receive 90 grams of white bread. On every 2 days of the experiment, after fasting for 10-12 hours, the participants will be asked to rate their feeling of fullness while fasting and at the time of 15, 30, 45, 60, 90 and 120 minutes after eating using the VAS questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age: 20 to 50 years old; healthy individuals; Body mass index in the range of 18.5-25; usual diet.
Exclusion criteria: FBS>105 mg/dl; Smoker; opioid addiction; pregnancy and breast feeding; special diet; professional sports exercises; digestive disorders; metabolic disorders; bariatric surgery and taking drugs that affect blood sugar metabolism; gastric emptying; weight and appetite.
Intervention groups
Intervention group: bread containing cumin; control group: white bread
Main outcome variables
Satiety index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160221026684N5
Registration date:2023-09-27, 1402/07/05
Registration timing:registered_while_recruiting
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
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
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of glycemic index of bread containing cumin in healthy individuals
Public title
Determining the satiety index of bread containing cumin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people
18.5 < BMI < 25
Have a usual diet
Exclusion criteria:
FBS>105 mg/dl
Smoker
Opioid addiction
Pregnancy and Breast feeding
Special diet
Professional sports exercises
Metabolic disorders
Digestive disorders
Bariatric surgery
Taking drugs that affect blood sugar metabolism, gastric emptying, weight and appetite
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
In terms of gender, age and body mass index, stratified randomization is performed. First, we prepare a complete list of volunteers to participate in the study, then based on age, sex and body mass index, it will be divided into three groups and randomization will be done in each layer. Finally, based on the above criteria, we will have two groups of random and layered.
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
2023-06-14, 1402/03/24
Ethics committee reference number
IR.SSU.REC.1402.035
Health conditions studied
1
Description of health condition studied
Healthy people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Satiety index
Timepoint
Measure satiety in fasting and every 15 minutes after eating each bread for up to two hours in the first week and second week
Method of measurement
Using the VAS Questionnaire and Formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 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
Category
Prevention
2
Description
Control group: Bread made from white wheat flour - The flour composition includes 98% white wheat flour + the remaining 2%, including sourdough and authorized bread additives such as salt and standard ingredients that improve the quality of bread
Category
Prevention
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
Amin Salehi Abargouei
Street address
Talar-e-Hanar Alley, North Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3727 9898
Email
abargoui@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
Satiety index 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 6 months 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