Study the combined effect of the Spinach and Okra on Sex hormones (LH, FSH, Testosterone, DHT, and DHEA) of obese men and women with type II diabetes
Design
This study is a non-blinded clinical trial. The study population will include all patients referred to the diabetes ward of Taleghani hospital of Kermanshah.
50 eligible patients will be selected conveniently and randomly will be assigned to two intervention groups.
Settings and conduct
This study which will be conducted in Taleghni hospital of Kermanshah is non-blinded one. Blood samples will be taken at baseline and 3 months after completion of the study, and sex hormone levels will be measured before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with type 2 diabetes; People over 30 years old; People with Kidney Failure Disease (CKD)
Exclusion criteria: People with type 1 diabetes; Pregnant women
Intervention groups
The intervention group will receive 2 grams of freshly dried spinach powder and 4 grams of fresh okra eggs before breakfast. The control group will receive no intervention
Main outcome variables
Sex hormones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N128
Registration date:2019-10-26, 1398/08/04
Registration timing:registered_while_recruiting
Last update:2019-10-26, 1398/08/04
Update count:0
Registration date
2019-10-26, 1398/08/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the combined effect of the Spinach and Okra on sex hormones (LH, FSH, Testosterone, DHT, and DHEA) of obese men and women with type II diabetes
Public title
Study the combined effect of the Spinach and Okra on sex hormones of obese men and women with type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with type 2 diabetes
People over 30 years old
BMI higher than 29.9
Exclusion criteria:
People with Kidney Failure Disease (CKD)
People with type 1 diabetes
pregnant women
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization method via code reception by 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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
ir.kums.rec.1398.621
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Sex hormones
Timepoint
At the beginning of the study and three months after the end of the study
Method of measurement
Using blood tests
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 2 grams of freshly dried spinach powder and 4 grams of fresh okra eggs before breakfast.
Category
Treatment - Other
2
Description
The control group will receive no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mohamad Rasoul Mohammadi
Street address
Diabetes Research Center, Taleghani Hospital, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 2014
Email
mohamadrasoul23.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamad Rasoul Mohammadi
Position
PhD student in medicine
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Parastar Boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
mohamadrasoul23.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Mehrali Rahimi
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology & Metabolism
Street address
Diabetes Research Center, Taleghani Hospital, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 2014
Email
mjavadra@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamad Rasoul Mohammadi
Position
PhD student in medicine
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Parastar Boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
mohamadrasoul23.m@gmail.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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 month
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail