Protocol summary
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Study aim
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Determination of glycemic index, glycemic load and satiety index of breads prepared from wheat flour-barley and wheat flour-oat flour in healthy individuals
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Design
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Randomized, not blinded, clinical trial in Phase 3 and for the determining the satiety index 30 healthy individuals are sufficient.
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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)
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Main outcome variables
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Glycemic index; glycemic load; satiety index
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-06-19, 1397/03/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-02, 1396/11/13
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Expected recruitment end date
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2018-05-03, 1397/02/13
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Actual recruitment start date
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2018-02-02, 1396/11/13
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Actual recruitment end date
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2018-05-03, 1397/02/13
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Trial completion date
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empty
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Scientific title
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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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Public title
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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
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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:
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Age
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From 20 years old to 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-15, 1396/10/25
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Ethics committee reference number
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IR.AJUMS.REC.1396.869
Health conditions studied
1
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Description of health condition studied
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healthy people
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Satiety index
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Timepoint
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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.
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Method of measurement
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Using the VAS Questionnaire and Formula
2
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Description
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Glycemic index
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Timepoint
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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.
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Method of measurement
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Using the glucometer device
Secondary outcomes
1
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Description
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Glycemic load
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Timepoint
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First week, second week, third week, forth week, fifth week, sixth week
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Method of measurement
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Using formula
Intervention groups
1
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Description
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Intervention group: Breads made with white wheat flour
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Category
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Lifestyle
2
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Description
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Intervention group: Bread made from blend of barley flour and white flour to a ratio of 1/2
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Category
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Lifestyle
3
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Description
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Intervention group: Bread made from blend of barley flour and white flour to a ratio of 1/4
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Category
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Lifestyle
4
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Description
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Intervention group: Bread made from blend of oat flour and white flour to a ratio of 1/2
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Category
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Lifestyle
5
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Description
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Intervention group: Bread made from blend of oat flour and white flour to a ratio of 1/4
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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40
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available