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Protocol summary

Study aim
Effect of oral black cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Design
This is a cross-over randomized placebo controlled double blind clinical trial. The target group consisted of 35 women who will randomly assigned into one of the two groups. Duration of the intervention consisted of 2 periods of 2 months;
Settings and conduct
Obese and overweight healthy women who will be referred to Imam Ali hospital in Yazd city, will be recruited and will be randomly divided into 2 groups of supplement and placebo; capsules will be given in a double-blind process; participants and researchers will be blinded to the content. Blood collection will be done to assess the biochemical factors at the beginning and the end of each period; RNA will be extracted from the blood of all participants before and after every intervention in the Internal section of hospital. RTPCR test will be performed on blood samples. After a 1-month washout, all the mentioned procedures will be done for the second period.
Participants/Inclusion and exclusion criteria
Inclusion criteria are healthy obese and overweight women aged 27 to 55 years old with the BMI ranges of 27 to 35 kg/m2; exclusion criteria includes the presence of allergy to the supplements during the intervention period or the use of less than 10% of the supplements.
Intervention groups
the treatment group will receive 2 pearls per day , that each pear contain 1000 ml of nigella sativa for 2 periods of 2 months; the placebo group will receive 2 pearls per day , that each pear contain 1000 ml of placebo for 2 periods of 2 months; one month of washout period will be performed between the 2 periods.
Main outcome variables
Adipogenesis related gene sequence; LDL-c; HDL-c; TG; TC; AST; ALT; ALK; SBP; DBP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180528039884N1
Registration date: 2018-07-02, 1397/04/11
Registration timing: prospective

Last update: 2019-02-15, 1397/11/26
Update count: 1
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Elham Razmpoosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3075
Email address
e.razmpoosh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral balck cumin (Nigella Sativa) supplement on the expression of genes involved in adipogenesis and serum concentrations of liver enzymes and lipid profiles among obese and overweight women
Public title
Effects of nigella satva on obesity related gene changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese women whose overweight and obesity were defined according to WHO criteria. The BMI range of participants should be between 27 to 35 kg/m2. Age ranges should be 25 to 55 years old. Healthy overweight and obese women will be interred to the study.
Exclusion criteria:
Having replacement treatments like Hormone or supplemental vitamins or weight loss drugs; tobacco and alcohol use chronic or acute inflammatory disease ; heart valve disease ; short bowel syndrome ; allergies individuals with low immune system (autoimmune diseases) pregnancy and lactation consuming less than 40% of Nigella sativa or placebo supplements. individuals who had allergy to the nigella sativa supplements.
Age
From 25 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
For the primary recruitment of participants, stratified randomization method will be used based on participants age including 25-40 and 40-55 years old. and the random number table will be used to assign participants to the intervention and control (placebo) groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The appearance and shape of the Supplements and placebos pearls will be similar; every complete packs will be given once for the first 2 months of the intervention and once before the second 2 months of the intervention. A and B labels will be fixed on the bottles of pearls by someone irrelevant to the entire study. Participants and researchers will be blinded to the contents in the bottles through out the study.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Faculty of Health, Shahid Sadoughi University of Medical Sciences
Street address
Alem Sauare
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2018-04-17, 1397/01/28
Ethics committee reference number
IR.SSU.SPH.REC.1397.007

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Alteration in adipogenesis related gene sequence
Timepoint
Four times; at the beginning and the end of the first 2-month trial and at beginning and the end of the second 2-month trial
Method of measurement
centrifuge

2

Description
Liver enzyme, alanine aminotransferase (ALT)
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)

3

Description
Lipid profile
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay kits (Padgin Teb Co.)

4

Description
Liver enzyme, Aspartate aminotransferase
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)

5

Description
Liver enzyme, Alkaline phosphatase (ALK)
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Assay Kits (Pars Azmoon Co.)

Secondary outcomes

1

Description
Blood Pressure
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
Mercury barometer

2

Description
anthropometric measurments
Timepoint
4 times; at the initiation and the end of the first 2-month trial and at the initiation and the end of the second 2-month trial
Method of measurement
digital anthropometric scale

Intervention groups

1

Description
Intervention group: the treatment group will receive 2 pearls of Nigella sativa per day after lunch and dinner, that each pearl contain 1000 ml of nigella sativa for 2 periods of 2 months; the pearls are produced by Barij Co.
Category
Treatment - Other

2

Description
Control group: the placebo group will receive 2 pearls per day , that each pear contain 1000 ml of placebo for 2 periods of 2 months; one month of washout period will be performed between the 2 periods. placebo will be the oral paraffin.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali clinic, related to Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3630 1700
Email
e_razmpoosh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com
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
50
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
Azadeh Nadjarzadeh
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadehnajarzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square
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
Azadeh Nadjarzadeh
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Alem Square- Pardis- faculty of Health
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9101
Email
azadehnajarzadeh@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
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
Some critical information such as the primary and secondary outcomes along with the informed consent form and volunteer related forms will be shared.
When the data will become available and for how long
6 months after the publication of the first related article
To whom data/document is available
Assistant professors and researchers, giving their detailed information and the reason for achieving the information.
Under which criteria data/document could be used
the permission from the correspondence
From where data/document is obtainable
Nutrition group, Faculty of Health, Shahid Sadoughi University of Medical Sciences
What processes are involved for a request to access data/document
discussing the request in Nutrition group and waiting for their assessment on the request
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