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The effect of addition of roasted chickpea flour on the glycemic index, glycemic load and satiety index of white bread

Protocol summary

Summary
This study examined the effect of adding chickpea flour to glycemic index, glycemic load and satiety index of white wheat bread. Study has two parts: 1-Determine the glycemic index and glycemic load, 2- Determine the satiety index of breads made from a mixture of white wheat flour and chickpea flour. To determine the glycemic index of breads, 10 healthy subjects enrolled in the study on 4 separate days with 1 week interval. In each day, they were given glucose solution, white bread or bread made from a mixture of white wheat flour and chickpea flour (1/2 and ¼). Blood sample were taken at fasting and at 15, 30, 45, 60, 90 and 120 minutes after food ingestion. Then the glycemic index and glycemic load were calculated using formula. In second part, for determining satiety index of breads, 20 healthy subjects enrolled in the study on three separate days with one week interval. In each day they are given white bread or bread made from a mixture of white wheat flour and chickpea flour. The satiety was measured at fasting and after bread ingestion, every 15min over the next 2 hours using a satiety questionnaire. Then the satiety index of breads calculated using formula. Finally the glycemic index, glycemic load and satiety index of the breads compared. In both parts of the study, each person consumed all test foods and they were their self-control.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061814680N4
Registration date: 2016-10-10, 1395/07/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Farideh Shishehbor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8430
Email address
shishehbor-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research Affairs of Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Expected recruitment start date
2015-10-17, 1394/07/25
Expected recruitment end date
2016-02-06, 1394/11/17
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of addition of roasted chickpea flour on the glycemic index, glycemic load and satiety index of white bread
Public title
The effect of roasted chickpea flour on the glycemic index, glycemic load and satiety index of white bread
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criter: age 20-50 year; healthy; normal diet; normal weight. Exclusion criteria:abnormality of glucose metabolism; smoking; pregnancy;lactation; having metabolic disease; taking medicine that affect blood glucose metabolism; any gastrointestinal impairment; having a special diet.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology Development of Ahvaz Jundishapur University of Medical S
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.AJUMS.REC.1394.232

Health conditions studied

1

Description of health condition studied
healty subjects
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Satiety index
Timepoint
Determining satiety rate at fasting and every 15 minutes after ingestion of breads for 2 hours
Method of measurement
Using VAS questionnaire and formula

2

Description
Glycemic index
Timepoint
Measuring blood glucose at fasting and at 15, 30, 45, 60, 90 and 120 minutes after food ingestion in week 1,week 2 and week 3
Method of measurement
Using formula

Secondary outcomes

1

Description
glycemic load
Timepoint
week 1, week 2, week 3
Method of measurement
using formula

Intervention groups

1

Description
white wheat bread
Category
Lifestyle

2

Description
Bread made from a mixture of white wheat flour and chickpea flour (1/2 ratio)
Category
Lifestyle

3

Description
Bread made from a mixture of white wheat flour and chickpea flour (1/4 ratio)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Nutrition and Metabolic Disease Research Center
Full name of responsible person
Farideh Shishehbor
Street address
Nutrition Department, Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Development of Ahvaz Jundishapur University of Medical
Full name of responsible person
Alireza Ekrami
Street address
Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Development of Ahvaz Jundishapur University of Medical
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Pardis Division of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham Kazem Assareh
Position
M.Sc student of Nutrition sciences
Other areas of specialty/work
Street address
Nutrition Department, Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 4253 4320
Fax
+98 61 3373 8330
Email
Elham.assareh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition and Metabolic Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farideh Shishehbor
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8430
Fax
Email
fari.shishehbor@gmail.com, shishehbor-f@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pardis Division of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham kazem Assareh
Position
M.Sc student of Nutrition Sciences
Other areas of specialty/work
Street address
Nutrition Department, Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 4253 4320
Fax
Email
Elham.assareh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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