The effect of okra powder (Abelmoschus esculentus) on blood sugar levels, inflammatory factors (IL-6, TNF)
Design
Randomized clinical trial, 80 patients, two groups of intervention and control based on a 4-item randomized block design. The type of intervention and control is indicated by A or B.
Settings and conduct
This study is performed in Golestan University of Medical Sciences and in Gorgan city on 80 pre-diabetic patients who are divided into two groups of 40 people. The first group receives 6 capsules of 500 mg of okra powder in three meals a day for 8 weeks. . The second group receives 6 placebo capsules (cryoxymethylcellulose) in three meals a day for 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having fasting blood sugar between 100 to 125 mg per deciliter, age 30 to 55 years, Iranian citizenship, informed consent, literacy.
Exclusion criteria: pregnancy and lactation in women, mental disorders that make it difficult to cooperate, concomitant diseases such as heart disease, renal failure, thyroid disease, inflammatory diseases and allergies, use of non-steroidal anti-inflammatory drugs, use steroid drugs
Intervention groups
The first group receives okra capsules. The second group receives placebo capsules (carboxymethylcellulose).
Main outcome variables
Lowering fasting blood sugar and hemoglobin A1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201026049154N1
Registration date:2020-11-08, 1399/08/18
Registration timing:prospective
Last update:2020-11-08, 1399/08/18
Update count:0
Registration date
2020-11-08, 1399/08/18
Registrant information
Name
Azadreza Mansourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 1653
Email address
azad_r_mansourian@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Okra( Abelmoschus esculentus ) Powder effects on Glucose Level, inflammatory factors ( IL-6،TNF-
Public title
The effect of okra powder on blood sugar levels in pre-diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood sugar between 100 and 125 mg per deciliter
Exclusion criteria:
Pregnancy and lactation in women
Existence of mental disorders at the same time that make it difficult to cooperate
Concomitant diseases such as heart disease, renal failure, thyroid disease, inflammatory diseases and allergies
Taking non-steroidal anti-inflammatory drugs
Taking steroid drugs
Age
From 30 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, using Excel software by computer, 80 random numbers with frequency A and B are generated in a row. Now, the researcher places the patient in one of these two groups of patients, from 1 to 80, depending on whether it is A or B for each of the cultivars.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know whether he is in the intervention group or placebo. The treating physician is not aware of how the patient is randomized to receive medication or placebo. The researcher and statistical consultant will not be aware of the intervention and placebo groupings.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Gorgan - Hyrkan Boulevard - Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-10-04, 1399/07/13
Ethics committee reference number
IR.GOUMS.REC.1399.229
Health conditions studied
1
Description of health condition studied
Pre-diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce fasting blood sugar
Timepoint
At the beginning of the study and after 8 weeks of consumption of okra powder
Method of measurement
Blood sample analysis
Secondary outcomes
1
Description
HbA1C
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Blood sample analysis
2
Description
Measurement of interleukin 6 (one of the inflammatory factors) in the blood
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Blood sample analysis
3
Description
Measurement of blood TNF-
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Blood sample analysis
4
Description
Evaluation of miR-15a expression (one of the diabetes-related miRs)
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
With Real-time pcr method
5
Description
Expression of miR-126 expression (one of the diabetes-related miRs)
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
With Real-time pcr method
Intervention groups
1
Description
Intervention group: 500 mg okra powder capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group will be prescribed. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests.
Category
Treatment - Drugs
2
Description
Placebo group: 500 mg carboxymethylcellulose capsules, two capsules, three times a day, half an hour before meals, orally for at least 8 weeks for randomized patients in this group. Blood samples will be taken from all patients before the intervention and after the intervention to perform tests.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Deziani Specialized Clinic
Full name of responsible person
Dr. Fatemeh Mohammadzadeh
Street address
Beheshti Street - in front of Behesht 17
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
msoheila66@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Azadreza Mansourian
Street address
Hyrkan Boulevard - Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
azad_r_mansourian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Afsharmanesh
Position
University student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Gorgan Jadid IV - Bahmaninejad Alley - Mahtab Building - Unit 6
City
Gorgan
Province
Golestan
Postal code
4913816364
Phone
+98 916 616 2697
Email
mra448@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Azad Reza Mansoorian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Hyrkan Blvd.-Kelestan University of Medical Sciences -Medical School of Biochemistry
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1653
Email
azad_r_mansourian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Afsharmanesh
Position
University student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Gorgan Jadid 4 - Bahmaninejad Alley - Mahtab Building Unit 6
City
Gorgan
Province
Golestan
Postal code
4913816364
Phone
+98 916 616 2697
Email
mra448@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
For the sake of transparency in the research process, all data can potentially be shared after identifying individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data obtained from this research can be used by different segments of the population.
Under which criteria data/document could be used
There are no restrictions on the use of data obtained from this study.
From where data/document is obtainable
The data obtained from this study are available in information databases.
What processes are involved for a request to access data/document
The data from this study are subject to public disclosure in the database without any restrictions, so no specific request or process is required.