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the effect of the glycemic index, glycemic load and satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects

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History
# Registration date Revision Id
2 2018-06-19, 1397/03/29 51234
1 2018-06-19, 1397/03/29 49722
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  • Protocol summary

    Determination of satiety index of breads prepared from wheat flour-barley and wheat flour-oat flour in healthy individuals
    Determination of glycemic index, glycemic load and satiety index of breads prepared from wheat flour-barley and wheat flour-oat flour in healthy individuals
    تعیین شاخص سیری نان های تهیه شده از مخلوط آرد گندم -آرد جو و آرد گندم -آرد جودوسر در افراد سالم
    تعیین شاخص گلیسمی، بار گلیسمی و شاخص سیری نان های تهیه شده از مخلوط آرد گندم -آرد جو و آرد گندم -آرد جودوسر در افراد سالم
    Randomized, not blinded, clinical trial in Phase 3 and for the determining the satiety index 20 healthy individuals are sufficient.
    Randomized, not blinded, clinical trial in Phase 3 and for the determining the satiety index 30 healthy individuals are sufficient.
    این مطالعه یک کارآزمایی بالینی تصادفی کور نشده در فاز 3 می باشد و تعداد 20 فرد سالم کافی است.
    این مطالعه یک کارآزمایی بالینی تصادفی کور نشده در فاز 3 می باشد و تعداد 30 فرد سالم کافی است.
    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.
    In this study will be participate 10 healthy people for determining the glyceamic index(GI) and load(GL), and 20 healthy people for determining the satiety index(SI). At the begining, people are referred to the laboratory after 10-12 hours fasting and a FBS sample is taken from them.Then glucose solution, breads containing white flour, white flour mixed by barley flour (with different proportions), and oat flour (with different proportions) are given to individuals. then, for determinding of the GI and GL, blood samples will be taken at intervals of 30, 15, 45, 60, 90 and 120 minutes after eating. and for determinding of SI, the questionnaire will determine the amount of satiety of individuals at fasting times and every 15 minutes to 120 minutes after eating breads containing white flour, white flour mixed by barley flour (with different proportions) and oat flour (with different proportions).
    در این مطالعه، 20 فرد سالم شرکت می کنند. افراد در ابتدای مطالعه پس از 10 تا 12 ساعت روزه داری در صبح در حالت ناشتا به منظور اندازه گیری FBS به آزمایشگاه مراجعه میکنند. در 5 روز جداگانه به فاصله ی یک هفته قبل و بعد از خوردن نان سفید (غذای مرجع)، نان های حاوی مخلوط آرد سفید و آرد جو و نان های حاوی مخلوط آرد سفید و آرد جودوسر با استفاده از پرسشنامه میزان سیری افراد در زمان های ناشتا و هر 15 دقیقه تا دقیقه 120، تعیین خواهد شد .
    در این مطالعه برای تعیین شاخص(GI) و بار گلیسمی (GL)، ده فرد سالم و 20 فرد سالم برای تعیین شاخص سیری (SI)، با سطح قند خون نرمال در مطالعه شرکت خواهند کرد. در ابتدای مطالعه، افراد پس از 12تا 10 ساعت روزه داری در حالت ناشتا و مراجعه به آزمایشگاه، یک نمونه خون ناشتا از آنها (هر 30نفر) گرفته می شود. 10 فرد سالم در 6 روز مختلف به فاصله یک هفته، محلول گلوکز، نان حاوی آرد سفید، نان های حاوی مخلوط آرد سفید و آرد جو (با نسبتهای متفاوت) و یا مخلوط آرد سفید و آرد جودوسر (با نسبتهای متفاوت) را مصرف می کنند. پس از آن به منظور تعیین GI و GLT،نمونه های خون در فاصله های 45،30،15، 60، 90 و 120 دقیقه پس از خوردن گرفته خواهد شد. و برای تعیین شاخص سیری، 20 فرد سالم در 5 روز جداگانه به فاصله ی یک هفته نان سفید (غذای مرجع)، نان های حاوی مخلوط آرد سفید و آرد جو و نان های حاوی مخلوط آرد سفید و آرد جودوسر را مصرف میکنند. قبل و بعد از خوردن با استفاده از پرسشنامه میزان سیری افراد در زمان های ناشتا و هر 15 دقیقه تا دقیقه 120،تعیین خواهد شد.
    satiety index
    Glycemic index; glycemic load; satiety index
    شاخص سیری
    شاخص گلایسمی؛ بار گلایسمی؛ شاخص سیری

  • General information

    20
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    20
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    20
    30
    Determination of the satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
    Determination of glycemic index, glycemic load and the satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
    تعیین شاخص سیری نان های تهیه شده از مخلوط آرد گندم- آرد جو و آرد گندم- آردجو دوسر در افراد سالم
    تعیین شاخص گلیسمی، بار گلیسمی و شاخص سیری نان های تهیه شده از مخلوط آرد گندم- آرد جو و آرد گندم- آردجو دوسر در افراد سالم
    the effect of the satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
    the effect of the glycemic index, glycemic load and satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
    بررسی شاخص سیری نان های تهیه شده از مخلوط آرد گندم- آرد جو و آرد گندم- آردجو دوسر در افراد سالم
    بررسی شاخص گلایسمی، بار گلایسمی و شاخص سیری نان های تهیه شده از مخلوط آرد گندم- آرد جو و آرد گندم- آردجو دوسر در افراد سالم

  • Primary outcomes

    #1
    empty
    Glycemic index
    empty
    شاخص گلایسمی
    empty
    Measurement of fasting and accurate fasting blood glucose levels at 15, 30, 45, 60, 90 and 120 after glucose and any of the breads in the first, second, third, fourth and fifth weeks.
    empty
    اندازه گیری میزان قند خون در حالت ناشتا و دقیق های 15، 30، 45، 60، 90 و 120 پس از خوردن محلول گلوکز و نیز هر کدام از نان ها، در هفته های اول، دوم، سوم، چهارم و پنجم
    empty
    Using the glucometer device
    empty
    با استفاده از دستگاه گلوکومتر

  • Secondary outcomes

    #1
    empty
    Glycemic load
    empty
    بار گلایسمی
    empty
    First week, second week, third week, forth week, fifth week, sixth week
    empty
    هفته اول، هفته دوم، هفته سوم، هفته چهارم، هفته پنجم، هفته ششم
    empty
    Using formula
    empty
    با استفاده از فرمول

  • Sponsors / Funding sources

    #1
    empty
    Yes
    دانشگاه علوم پزشکی اهواز
    دانشگاه علوم پزشکی اهواز

Protocol summary

Study aim
Determination of glycemic index, glycemic load and 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 30 healthy individuals are sufficient.
Settings and conduct
In this study will be participate 10 healthy people for determining the glyceamic index(GI) and load(GL), and 20 healthy people for determining the satiety index(SI). At the begining, people are referred to the laboratory after 10-12 hours fasting and a FBS sample is taken from them.Then glucose solution, breads containing white flour, white flour mixed by barley flour (with different proportions), and oat flour (with different proportions) are given to individuals. then, for determinding of the GI and GL, blood samples will be taken at intervals of 30, 15, 45, 60, 90 and 120 minutes after eating. and for determinding of SI, the questionnaire will determine the amount of satiety of individuals at fasting times and every 15 minutes to 120 minutes after eating breads containing white flour, white flour mixed by barley flour (with different proportions) and oat flour (with different proportions).
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
Glycemic index; glycemic load; 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: 2018-07-02, 1397/04/11
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 glycemic index, glycemic load and satiety index of breads made with wheat flour-barley flour and wheat flour-oat flour in healthy subjects
Public title
Determination of glycemic index, glycemic load and 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 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
2018-01-15, 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

2

Description
Glycemic index
Timepoint
Measurement of fasting and accurate fasting blood glucose levels at 15, 30, 45, 60, 90 and 120 after glucose and any of the breads in the first, second, third, fourth and fifth weeks.
Method of measurement
Using the glucometer device

Secondary outcomes

1

Description
Glycemic load
Timepoint
First week, second week, third week, forth week, fifth week, sixth week
Method of measurement
Using formula

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?
Yes
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
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