Determination of glycemic index, glycemic load and satiety index of cookies prepared from white wheat flour and whole oleaster powder In healthy people
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, cookies containing white flour, white flour mixed by whole oleaster powder (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 bread containing white flour and cookies containing white flour,white flour mixed by whole oleaster powder (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, cookies prepared from white wheat flour and whole oleaster powder.
Main outcome variables
Glycemic index; glycemic load; satiety index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181016041362N1
Registration date:2018-11-19, 1397/08/28
Registration timing:prospective
Last update:2018-11-19, 1397/08/28
Update count:0
Registration date
2018-11-19, 1397/08/28
Registrant information
Name
Jomaneh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 7142
Email address
jheidari93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey glycemic index, glycemic load and satiety index of cookies prepared from white wheat flour and whole oleaster powder In healthy people
Public title
Determination of glycemic index, glycemic load and satiety index of cookies prepared from white wheat flour and whole oleaster powder In healthy people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The level of fasting blood glucose in the normal range (less than 110 mg / ml) normal BMI range (18.5 to 24.9 kg / m 2) following the usual diet
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway
City
َAhvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.AJUMS.REC.1397.478
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
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 and third weeks.
Method of measurement
Using the glucometer device
Secondary outcomes
1
Description
Glycemic load
Timepoint
First week, second week, third week
Method of measurement
Using formula
Intervention groups
1
Description
Intervention group: cookies made from white wheat flour, water, baking powder, salt and oil, which each person randomly consumes once in the course of this 4-week intervention. This cookie 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: cookies made from mixture of whole oleaster powder and white flour to a ratio of 1/2, water, baking powder, salt and oil, which each person randomly consumes once in the course of this 4-week intervention.This cookie 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: cookies made from mixture of 1/4 whole oleaster powder and 3/4 white flour , water,baking powder, salt and oil, which each person randomly consumes once in the course of this 4-week intervention. This cookie 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
Jomaneh heidari
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 3338 7142
Email
jheidari93@gmail.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
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
Jomaneh Heidari
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 3338 7142
Email
jheidari93@gmail.com
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