The effect of Quercus flour on the glycemic index, glycemic load and satiety index of white bread in healthy subjects
Design
Randomized, not blinded, clinical trial in Phase 3. For determining the glycemic index, 10 healthy individuals are sufficient and 20 healthy individuals are sufficient for the satiety index.
Settings and conduct
This study will be carried out at Ahvaz Jundishapur University of Medical Sciences. To determine the glycemic index and load, 10 healthy people with a normal blood sugar level will participate in the study. In each day of the study, people are referred to the laboratory after 10 to 12 hours fasting and a fasting blood sample is taken from them.Then glucose solution, white bread or two breads containing white flour and Quercus flour (with different proportions) are given to individuals. After that, blood samples will be taken at intervals of 30, 15, 45, 60, 90 and 120 minutes after eating.In order to determine the satiety index, 20 healthy people refer to the laboratory in the fasting state for three separate days, one week after 10-12 hours fasting. Before and after eating white bread (reference food) and breads containing white flour and Quercus flour, the questionnaire will determine the amount of satiety of individuals at fasting times and every 15 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both sexes؛ ages 20-40 years؛ Fasting blood sugar levels within the normal range (less than 110 mg / dl)؛ BMI in the normal range (18.5 to 24.9 kg / m 2) ؛ 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 and bread mixed with white flour and oak flour (with different proportions).
Main outcome variables
Glycemic index; glycemic load; satiety index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038584N1
Registration date:2018-07-04, 1397/04/13
Registration timing:retrospective
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Zahra Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 3969
Email address
zf.salimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-17, 1396/10/27
Expected recruitment end date
2018-02-17, 1396/11/28
Actual recruitment start date
2018-01-17, 1396/10/27
Actual recruitment end date
2018-02-17, 1396/11/28
Trial completion date
empty
Scientific title
The effect of Quercus flour on the glycemic index, glycemic load and satiety index of white bread in healthy subjects
Public title
Determination of Quercus Flour effect on the glycemic index, glycemic load and satiety index of white bread 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 diet
Exclusion criteria:
Taking medications and diseases that affect the metabolism of blood sugar and the amount of hunger and satiety.
Pregnancy
Lactation
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
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
2018-01-16, 1396/10/26
Ethics committee reference number
IR.AJUMS.REC.1396.870
Health conditions studied
1
Description of health condition studied
افراد سالم
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 and the third week
Method of measurement
Using the VAS Questionnaire and Formula
2
Description
Glycemic index
Timepoint
Blood glucose measurements in fasting state and 90, 60, 45, 30, 15 and 120 minutes after eating
Method of measurement
Using formula
Secondary outcomes
1
Description
Glycemic load
Timepoint
First week, second week, third week
Method of measurement
Using formula
Intervention groups
1
Description
Intervention group: Breads made from white wheat flour, water, improver, salt and yeast, which each person randomly consumes once in the course of this 4-week intervention. This bread should contain 50 grams of available carbohydrates for the glycemic index and 1,000 kiloules (240 kilocalories) of energy for the Satiety index.
Category
Lifestyle
2
Description
Intervention group: Bread made from mixture of oak flour and white flour to a ratio of 1/2, water, improver, salt and dough, which each person randomly consumes once in the course of this 4-week intervention.This bread should contain 50 grams of available carbohydrates for the glycemic index and 1,000 kiloules (240 kilocalories) of energy for the Satiety index.
Category
Lifestyle
3
Description
Intervention group: Bread made from mixture of 1/4 oak flour and 3/4 white flour , water, improver, salt and dough, which each person randomly consumes once in the course of this 4-week intervention. This bread should contain 50 grams of available carbohydrates for the glycemic index and 1,000 kiloules (240 kilocalories) of energy for the Satiety index.
Category
Lifestyle
4
Description
Intervention group: Glucose solution(50 g dissolved in 250 ml of water) used to determine the glycemic index as a reference food.
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?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Salimi
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
salimi.z@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
Zahra Salimi
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
salimi.z@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