Determining The effect of barley Savigh consumption on blood sugar in predibetic menopausal women
Design
A randomized controlled clinical trial with parallel, randomized groups
Settings and conduct
This study is conducted in community health centers of Gonabad city.Pre-diabetics in the intervention group receive 60 grams of barley savigh daily for 4 weeks.Before the intervention and at the end of weeks 2 and 4, fasting blood sugar and blood sugar two hours after food are checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria include being pre-diabetic (fasting blood sugar between 100 and 125 or two hours after food between 140-199 mg / dL), menopause, age 45 to 65, no antidiabetic drugs, no diseaseCardiovascular, renal, hepatic, thyroid, and blood pressure, and exclusion criteria include the need to start insulin therapy or hypoglycemic drugs, Lack of regular consumption of barley savigh and causing complications in the person.
Intervention groups
The intervention group includes pre-diabetic women who receive intervention in the form of barley savigh. The control group includes pre-diabetic women who are not treated.
Main outcome variables
Blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200929048880N1
Registration date:2020-10-25, 1399/08/04
Registration timing:registered_while_recruiting
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
khadije kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 2883
Email address
kamali.kh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of barley Savigh consumption on blood sugar in predibetic menopausal women, Gonabad-2020
Public title
The effect of barley Savigh consumption on blood sugar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pre-diabetic women (fasting blood sugar between 100 and 125 or blood sugar two hours after a food between 140 and 199 mg / dL
Menopause(having amenorrhea for at least 12 months)
Age 65-45 years
No diabetes
Do not take anti-diabetic drugs
No cardiovascular, renal, hepatic, thyroid and hypertensive diseases
No history of smoking, drugs or alcohol
Literate to read and write
No history of grain allergy
Body mass index 19/8 to 29
Exclusion criteria:
Incidence of diabetes during the study period
Need to start insulin therapy or blood sugar-lowering drugs during the study period
Occurrence of stressful events during the study period
Lack of regular consumption of barley savigh
Complication of the individual
Hospitalization during the intervention
Failure to complete the nutrition and physical activity questionnaire
Incidence of hypoglycemia during the intervention
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
By referring to the community health centers of Gonabad city, people with inclusion criteria are selected by easy sampling method. Individuals will be assigned to intervention and control groups using a randomized block-by-block method with random number table.
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.GMU.REC.1399.070
Health conditions studied
1
Description of health condition studied
Pre-diabetes
ICD-10 code
R73.01
ICD-10 code description
Impaired fasting glucose
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Initially and 2 and 4 weeks after the study
Method of measurement
Standards of medical diagnostic laboratories
2
Description
2 hour postprandial plasma glucose
Timepoint
Initially and 2 and 4 weeks after the study
Method of measurement
Standards of medical diagnostic laboratories
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Consumption of 60 grams of barley savigh (20 grams before each meal) for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers of Gonabad city
Full name of responsible person
Khadije Kamali
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
khkamali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691837173
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Khadije Kamali
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, South Adalat Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
96911-73655
Phone
+98 51 5723 2883
Fax
Email
kamali.kh@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Khadije Kamali
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, South Adalat Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
96911-73655
Phone
+98 51 5723 2883
Fax
Email
kamali.kh@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Khadije Kamali
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 84, South Adalat Ave.
City
Gonabad
Province
Razavi Khorasan
Postal code
96911-73655
Phone
+98 51 5723 2883
Fax
Email
kamali.kh@gmu.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