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General information
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Measuring other factors related to Insulin Resistance in women with obesity and Overweight (funding provided)
Measuring other factors related to Insulin Resistance in women with obesity and Overweight (funding provided)
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اندازه گیری دیگر فاکتورهای مرتبط با مقاومت انسولینی در زنان دارای چاقی و اضافه وزن (بودجه تامین شده)
اندازه گیری دیگر فاکتورهای مرتبط با مقاومت انسولینی در زنان دارای چاقی و اضافه وزن (بودجه تامین شده)
Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance, glycemic status and anthropometric indices among obese women
Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance and inflammation among obese women
Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance, glycemic status and anthropometric indicesinflammation among obese women
بررسی اثر مکمل خوراکی Nigella Sativa بر بیان ژنهای مرتبط با مقاومت به انسولین، وضعیت گلایسمی و اندازه های آنتروپومتری در زنان چاق
بررسی اثر مکمل خوراکی Nigella Sativa بر بیان ژنهای مرتبط با مقاومت به انسولین و التهابی در زنان چاق
بررسی اثر مکمل خوراکی Nigella Sativa بر بیان ژنهای مرتبط با مقاومت به انسولین، وضعیت گلایسمی و اندازه های آنتروپومتریالتهابی در زنان چاق
Primary outcomes
#1
serum leptin level
Serum malondialdehyde level
serum leptinSerum malondialdehyde level
سطح لپتین سرم
سطح مالون دی آلدهید سرم
سطح لپتینمالون دی آلدهید سرم
ELISA Kit
ELISA kit
ELISA Kitkit
#2
serum IL-6 level
Serum total anti-oxidant capacity
serum ILSerum total anti-6 leveloxidant capacity
سطح IL-6 سرم
ظرفیت کل آنتی اکسیدانی سرم
سطح IL-6ظرفیت کل آنتی اکسیدانی سرم
ELISA Kit
ELISA kit
ELISA Kitkit
#3
Serum malondialdehyde level
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Serum malondialdehyde level
سطح مالون دی آلدهید سرم
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سطح مالون دی آلدهید سرم
at the beginning and end of each 2-month intervention period
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at the beginning and end of each 2-month intervention period
ابتدا و انتهای هر دوره 2 ماهه مداخله
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ابتدا و انتهای هر دوره 2 ماهه مداخله
ELISA kit
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ELISA kit
کیت الایزا
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کیت الایزا
#4
Serum total anti-oxidant capacity
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Serum total anti-oxidant capacity
ظرفیت کل آنتی اکسیدانی سرم
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ظرفیت کل آنتی اکسیدانی سرم
at the beginning and end of each 2-month intervention period
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at the beginning and end of each 2-month intervention period
ابتدا و انتهای هر دوره 2 ماهه مداخله
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ابتدا و انتهای هر دوره 2 ماهه مداخله
ELISA kit
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ELISA kit
کیت الایزا
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کیت الایزا
Secondary outcomes
#1
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Appetite
Appetite
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اشتها
اشتها
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At the beginning and end of each 2-month intervention period
At the beginning and end of each 2-month intervention period
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ابتدا و انتهای هر دوره 2 ماهه مداخله
ابتدا و انتهای هر دوره 2 ماهه مداخله
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visual analog scale questionnaire
visual analog scale questionnaire
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پرسشنامه VAS
پرسشنامه VAS
#2
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Dietary intake
Dietary intake
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دریافت غذایی
دریافت غذایی
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At the beginning and end of each 2-month intervention period
At the beginning and end of each 2-month intervention period
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ابتدا و انتهای هر دوره 2 ماهه مداخله
ابتدا و انتهای هر دوره 2 ماهه مداخله
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three-day food records and 24-h food recalls questionnaires
three-day food records and 24-h food recalls questionnaires
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پرسشنامه یاددامد 24 ساعته و یادداشت خوراک 3 روزه
پرسشنامه یاددامد 24 ساعته و یادداشت خوراک 3 روزه
#3
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Expression of hormone-related genes in peripheral blood mononuclear cells
Expression of hormone-related genes in peripheral blood mononuclear cells
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میزان بیان ژن های وابسته به هورمون در سلول های تک هسته ای خون محیطی
میزان بیان ژن های وابسته به هورمون در سلول های تک هسته ای خون محیطی
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at the beginning and end of each 2-month intervention period
at the beginning and end of each 2-month intervention period
Of the obese women referring to the Imam Ali Clinic in Yazd, 40 people will be selected and randomly divided into two groups. The participants and investigator will not be aware of the drugs and placebo. The amount of genes expression in PBMC will be measured before and after the end of each stage of the intervention. Intervention is crossover and is performed in two stages of 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Obese women with BMI between 27 to 35 kg/m2 and age between 25 to 55. Subjects should not use any drug. Should not have diabetes or pre-diabetes or dyslipidemia.
Exclusion criteria:
People who smoke or drink alcohol, pregnant and nursing women, People with chronic kidney or liver disease.
Expression of genes involved in insulin resistance in peripheral blood mononuclear cells;
Fasting blood glucose;
Serum insulin level;
Serum leptin level;
Serum IL-6 level;
Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, waist to hip ratio);
Body composition.
General information
Reason for update
Measuring other factors related to Insulin Resistance in women with obesity and Overweight (funding provided)
Acronym
IRCT registration information
IRCT registration number:IRCT20180430039475N1
Registration date:2018-06-25, 1397/04/04
Registration timing:prospective
Last update:2021-11-20, 1400/08/29
Update count:5
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Sara Safi Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 5375
Email address
drsafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance and inflammation among obese women
Public title
Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese women with BMI between 27 to 35 kg/m2
Age between 25 to 55
Should not use any drug
Should not have diabetes or pre-diabetes or dyslipidemia
Exclusion criteria:
People who smoke or drink alcohol
Pregnant and nursing women
People with chronic kidney, liver disease
Age
From 25 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
1
Blood samples will be taken from all individuals before and after each period of interventions.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Simple
Random unit: Individual
Tool: Randomized Tables
A balanced block method is used to allocate concealment so that the number of samples assigned to each of the groups is equal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements of cumin and placebo in the same capsules in terms of size, color and shape
Encodes A and B on supplements and placebo
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd
Street address
School of health, Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Alem Sq.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-04-17, 1397/01/28
Ethics committee reference number
IR.SSU.SPH.REC.1397.006
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Expression of genes involved in insulin resistance in peripheral blood mononuclear cells
Timepoint
at the beginning and end of each 2-month intervention period
at the beginning and end of each 2-month intervention period
Method of measurement
ELISA kit
5
Description
serum level of sex-hormone binding globulin
Timepoint
at the beginning and end of each 2-month intervention period
Method of measurement
ELISA kit
Intervention groups
1
Description
Intervention group: People in this group will recieve two 1000 mg capsules of Nigella Sativa daily for 8 weeks. Then it will be wash out period for 1 month, and after that, people will receive 2 placebo capsules daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group:people in this group will recieve two placebo capsuls daily for 8 weeks. Then it will be wash out period for 1 month, and after that, people will receive two 1000 mg capsules of Nigella Sativa daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali clinic
Full name of responsible person
Sara Safi Esfahani
Street address
Navab Safavi Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3630 1700
Email
dr.s_safi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Research Associate, School of Health
Street address
Shohadaye gomnam Blvd., Shahid Sadoughi University of Medical Sciences, School of Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
sphealth@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sara Safi Esfahani
Position
Phd Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
drsafi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sara Safi Esfahani
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
drsafi@ssu.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
I have not yet decided on this.
When the data will become available and for how long
I have not yet decided on this.
To whom data/document is available
I have not yet decided on this.
Under which criteria data/document could be used
I have not yet decided on this.
From where data/document is obtainable
I have not yet decided on this.
What processes are involved for a request to access data/document