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IRCT20180528039884N1 IRCT 2018-07-02 Yazd University of Medical Sciences Effects of nigella satva on obesity related gene changes 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 2018-07-23 anticipated 35 Complete https://irct.ir/trial/31732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, 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 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. 3 Obesity and overweight. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Some critical information such as the primary and secondary outcomes along with the informed consent form and volunteer related forms will be shared. When: 6 months after the publication of the first related article To whom: Assistant professors and researchers, giving their detailed information and the reason for achieving the information. Conditions: the permission from the correspondence Where to obtain: Nutrition group, Faculty of Health, Shahid Sadoughi University of Medical Sciences How to obtain: discussing the request in Nutrition group and waiting for their assessment on the request Comments:
public Azadeh Nadjarzadeh
Alem Square
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences scientific Azadeh Nadjarzadeh
Alem Square
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 25 years 55 years Female 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. E66.9 Obesity, unspecified Treatment - Other Placebo 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. 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. 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. 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.). 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.). 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.). 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.). 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. 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. Yazd University of Medical Sciences Approved 2018-04-17 Ethic committee of Faculty of Health, Shahid Sadoughi University of Medical Sciences Alem Sauare Yazd Yazd Iran (Islamic Republic of)