Protocol summary
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Study aim
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Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance among obese women
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Design
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randomized double blind controlled clinical trial, cross-over
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group: capsule containing 1000 mg Nigella Sativa oil twice daily
Control group: Placebo capsule containing paraffin oil twice daily
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Main outcome variables
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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;
General information
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Reason for update
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Measuring other factors related to Insulin Resistance in women with obesity and Overweight (funding provided)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180430039475N1
Registration date:
2018-06-25, 1397/04/04
Registration timing:
prospective
Last update:
2022-04-05, 1401/01/16
Update count:
5
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Registration date
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2018-06-25, 1397/04/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-07-23, 1397/05/01
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Expected recruitment end date
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2019-03-20, 1397/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance and inflammation among obese women
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Public title
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Effect of Nigella Sativa supplement on the expression of genes involved in insulin resistance
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 55 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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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.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Supplements of cumin and placebo in the same capsules in terms of size, color and shape
Encodes A and B on supplements and placebo
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-17, 1397/01/28
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Ethics committee reference number
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IR.SSU.SPH.REC.1397.006
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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Expression of genes involved in insulin resistance in peripheral blood mononuclear cells
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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Reverse transcription polymerase chain reaction (RT-PCR)
2
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Description
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fasting blood glucose
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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Biochemical analysis
3
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Description
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Serum insulin level
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA Kit
4
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Description
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Serum malondialdehyde level
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
5
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Description
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Serum total anti-oxidant capacity
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
6
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Description
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serum leptin
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
7
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Description
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serum IL-6
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
Secondary outcomes
1
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Description
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Dietary intake
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Timepoint
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At the beginning and end of each 2-month intervention period
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Method of measurement
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three-day food records and 24-h food recalls questionnaires
2
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Description
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Expression of hormone-related genes in peripheral blood mononuclear cells
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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Reverse transcription polymerase chain reaction (RT-PCR)
3
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Description
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serum level of estradiol
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
4
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Description
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serum level of sex-hormone binding globulin
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Timepoint
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at the beginning and end of each 2-month intervention period
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Method of measurement
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ELISA kit
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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I have not yet decided on this.
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When the data will become available and for how long
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I have not yet decided on this.
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To whom data/document is available
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I have not yet decided on this.
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Under which criteria data/document could be used
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I have not yet decided on this.
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From where data/document is obtainable
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I have not yet decided on this.
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What processes are involved for a request to access data/document
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I have not yet decided on this.
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Comments
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