Determination of satiety index of breads prepared from wheat flour-barley and wheat flour-oat flour in healthy individuals
Design
Randomized, not blinded, clinical trial in Phase 3 and for the determining the satiety index 20 healthy individuals are sufficient.
Settings and conduct
At the begining of the study 20 healthy people, are referred to the laboratory after 10-12 hours fasting and a FBS sample is taken from them.In five separate days, one week before and after eating white bread (reference food), breads containing white flour and barley flour and breads containing white flour and oat flour using a questionnaire on the amount of syrup of individuals at times Fasting and every 15 minutes to 120 minutes will be determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both sexes؛ ages 20-40 years؛ FBS levels (< 110 mg / dl) and BMI(18.5 to 24.9 kg / m 2) within the normal range؛ following a common diet exclusion criteria: Pregnancy؛ Breast feeding؛ the use of drugs and diseases that affect the metabolism of blood sugar and the amount of the satiety and hunger
Intervention groups
Healthy people consume white bread, bread mixed with white flour and barley flour (with different proportions) and bread mixed with white flour and oat flour (with different proportions)
Main outcome variables
satiety index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039780N1
Registration date:2018-06-19, 1397/03/29
Registration timing:retrospective
Last update:2018-06-19, 1397/03/29
Update count:1
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Mohadeseh Zendehdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3663 8798
Email address
salimi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-02, 1396/11/13
Expected recruitment end date
2018-05-03, 1397/02/13
Actual recruitment start date
2018-02-02, 1396/11/13
Actual recruitment end date
2018-05-03, 1397/02/13
Trial completion date
empty
Scientific title
the effect of the satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
Public title
Determination of the satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The level of fasting blood glucose is normal (less than 110 mg / ml)
BMI normal (18.5 to 24.9)
Follow the normal dietBMI
Exclusion criteria:
Age
From 20 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.AJUMS.REC.1396.869
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, the second week, the third week, forth week and fifth week.
Method of measurement
Using the VAS Questionnaire and Formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Breads made with white wheat flour
Category
Lifestyle
2
Description
Intervention group: Bread made from blend of barley flour and white flour to a ratio of 1/2
Category
Lifestyle
3
Description
Intervention group: Bread made from blend of barley flour and white flour to a ratio of 1/4
Category
Lifestyle
4
Description
Intervention group: Bread made from blend of oat flour and white flour to a ratio of 1/2
Category
Lifestyle
5
Description
Intervention group: Bread made from blend of oat flour and white flour to a ratio of 1/4
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition and Metabolic Diseases Research Center
Full name of responsible person
Farideh Shishehbor
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3384 3001
Email
fari.shishehbor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
40
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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohaddese Zendehdel
Position
Masters of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
zendehdel.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farideh Shishehbor
Position
PhD Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Email
shishehbor.f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohaddese Zendehdel
Position
Masters of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
zendehdel.m@ajums.ac.ir
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