Protocol summary
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Study aim
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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
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Design
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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;
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Adipogenesis related gene sequence; LDL-c; HDL-c; TG; TC; AST; ALT; ALK; SBP; DBP
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-07-02, 1397/04/11
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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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2019-03-06, 1397/12/15
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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 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
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Public title
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Effects of nigella satva on obesity related gene changes
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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 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.
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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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Sample size
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Target sample size:
35
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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.1397.007
Health conditions studied
1
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Description of health condition studied
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Obesity and overweight
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ICD-10 code
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E66.9
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ICD-10 code description
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Obesity, unspecified
Primary outcomes
1
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Description
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Alteration in adipogenesis related gene sequence
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Timepoint
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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
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Method of measurement
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centrifuge
2
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Description
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Liver enzyme, alanine aminotransferase (ALT)
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Timepoint
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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
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Method of measurement
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Assay Kits (Pars Azmoon Co.)
3
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Description
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Lipid profile
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Timepoint
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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
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Method of measurement
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Assay kits (Padgin Teb Co.)
4
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Description
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Liver enzyme, Aspartate aminotransferase
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Timepoint
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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
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Method of measurement
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Assay Kits (Pars Azmoon Co.)
5
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Description
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Liver enzyme, Alkaline phosphatase (ALK)
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Timepoint
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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
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Method of measurement
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Assay Kits (Pars Azmoon Co.)
Secondary outcomes
1
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Description
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Blood Pressure
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Timepoint
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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
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Method of measurement
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Mercury barometer
2
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Description
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anthropometric measurments
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Timepoint
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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
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Method of measurement
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digital anthropometric scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
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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50
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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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Yes - There is 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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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some critical information such as the primary and secondary outcomes along with the informed consent form and volunteer related forms will be shared.
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When the data will become available and for how long
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6 months after the publication of the first related article
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To whom data/document is available
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Assistant professors and researchers, giving their detailed information and the reason for achieving the information.
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Under which criteria data/document could be used
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the permission from the correspondence
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From where data/document is obtainable
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Nutrition group, Faculty of Health, Shahid Sadoughi University of Medical Sciences
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What processes are involved for a request to access data/document
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discussing the request in Nutrition group and waiting for their assessment on the request
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Comments
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