The effect of date seed powder on the glycemic index, glycemic load and satiety index of white bread in healthy subjects
Design
Clinical trial, crossover, controlled
Settings and conduct
The study will be conducted 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 for 4 different day after 10-12 hours fasting and a fasting blood sample is taken from them.Then glucose solution, white bread or two breads containing white flour and date seed powder 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 after 10-12 hours fasting. Before and after eating white bread and breads containing white flour and date seed powder, 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؛ 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؛ lactation؛ 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 date seed powder (with different proportions).
Main outcome variables
Glycemic index; glycemic load; satiety index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191126045509N1
Registration date:2019-12-30, 1398/10/09
Registration timing:registered_while_recruiting
Last update:2019-12-30, 1398/10/09
Update count:0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Fateme Kiany Servak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8253
Email address
kiany.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding date seed powder on the glycemic index, glycemic load and satiety index of white bread in healthy subjects
Public title
The effect of date seed powder on the glycemic index, glycemic load and satiety index
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
FBS levels < 110 mg / dl
BMI(18.5 to 24.9 kg / m 2) within the normal range
following a common diet
Exclusion criteria:
Pregnancy
lactation
the use of drugs and diseases that affect the metabolism of blood sugar and the amount of the satiety and hunger
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
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
2019-11-23, 1398/09/02
Ethics committee reference number
IR.AJUMS.REC.1398.619
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 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: 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: Each individual will consume a bread made of a mixture of 40% date seed powder and 60%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: Each individual will consume a bread made of a mixture of 20%date seed powder and 80% 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
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, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farideh Shishehbor
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3373 8253
Fax
+98 61 3373 8253
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
Fax
+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
Fateme Kiany Servak
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan highway.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
kiany.f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farideh Shishebor
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
Fateme Kiany Servak
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Para-Medicine School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
kiany.f@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the financial support of this research project by Ahvaz Jundishapur University of Medical Sciences, the study data will not be allowed to be published after the intervention.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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