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The effect of soybean flour on the glycemic index, glycemic load and satiety index of white bread in healthy subjects

Protocol summary

Study aim
The effect of soybean flour on glycemic index, glycemic load,satiety index of white bread in healthy subjects
Design
Clinical trial, crossover, controlled
Settings and conduct
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 10-12 hours fasting and a fasting blood sample is taken from them.Then glucose, white bread or two breads containing white flour and soybean flour 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 and breads containing white flour and soybean 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: ages 20-40 years; Fasting blood sugar levels less than 110 mg / dl; Body mass index in the normal range (18.5 to 24.9 kg / m 2); following a common diet exclusion criteria: Pregnancy; Breast feeding; using drugs and diseases that affect metabolism of blood sugar and satiety and hunger.
Intervention groups
In intervention groups, 3 types of breads will be given, that each should contain 50 grams of available carbohydrates. Intervention group 1: white wheat flour bread Intervention group 2: bread made of equal amounts of soybean flour and white flour Intervention group 3: bread made of a mixture of 25% soybean flour and 75% white flour Control group: consuming glucose solution (50 grams of glucose dissolved in 250 ml of water)
Main outcome variables
Glycemic index; glycemic load; satiety index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181017041366N1
Registration date: 2018-12-19, 1397/09/28
Registration timing: prospective

Last update: 2018-12-19, 1397/09/28
Update count: 0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Somayeh Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3355 7288
Email address
somayeh.mirzaei48@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of soybean flour on the glycemic index, glycemic load and satiety index of white bread in healthy subjects
Public title
Effect of soybean flour on the glycemic index, glycemic load and satiety index of white bread
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The level of fasting blood glucose is normal (less than 110 mg / ml) Body mass index normal (18.5 to 24.9) Follow the normal diet
Exclusion criteria:
Taking medications that affect the metabolism of blood sugar and the amount of hunger and satiety. 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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.AJUMS.REC.1397.477

Health conditions studied

1

Description of health condition studied
glycemic index in healthy people
ICD-10 code
ICD-10 code description

2

Description of health condition studied
glycemic load in healthy people
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Satiety index in 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 and the third week
Method of measurement
Using the visual analog scale questionnaire and formula

2

Description
Glycemic index
Timepoint
Blood glucose measurements in fasting state and15، 30، 45، 60، 90، 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 group1: Each individual will consume a bread made of white wheat flour, water, improver, salt and yeast. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.
Category
Lifestyle

2

Description
Intervention group 2: Each individual will consume a bread made of a mixture of equal amounts of soybean flour and white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.
Category
Lifestyle

3

Description
Intervention group 3: Each individual will consume a bread made of a mixture of 25% soybean flour and 75% white flour, water, improver, salt and dough. This bread should contain 50 grams of available carbohydrates and 1,000 Kilojoules (240 kilocalories) of energy.
Category
Lifestyle

4

Description
Control 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 Disease Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farideh Shishehbor
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3373 8253
Fax
+98 61 3373 8253
Email
NRC@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
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
Somayeh Mirzaei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Building Co-operation of Municipalities, Baharestan 29, Ashoori Street, Bushehr,
City
Boushehr
Province
Boushehr
Postal code
7515799999
Phone
+98 77 3355 7288
Fax
Email
somayeh.mirzaei48@yahoo.com

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
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
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
Somayeh Mirzaei
Position
Masters of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
The building of the Municipal Organization of Organizations, Baharestan 29, Ashoori Street
City
Bushehr
Province
Boushehr
Postal code
7515799999
Phone
+98 77 3355 7288
Email
mirzaei.s@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
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