]>
IRCT20131125015542N2 IRCT 2018-11-24 Ahvaz University of Medical Sciences Effect of Taurine in obesity Evaluation of the effect of oral taurine supplementation on Serum levels of fibroblast growth factors ( FGF19, FGF21), β-Klotho co-receptor, glycemic status, lipid profile, adipocytokines, hs-CRP and body composition in obese women on a weight-loss diet 2018-12-05 anticipated 50 Complete https://irct.ir/trial/33793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible subjects will be divided randomly into two groups including control and intervention. Randomization will be performed using the computer-generated random numbers. the naming of taurine or placebo bottles will be done based on random numbers and odd or even numbers will be allocated to the A or B group. To achieve allocation concealment, the bottles will be sealed and we will be assured from the similarity of appearance and their weight. The randomization process will be performed by an individual other than the investigators to reduce the probable bias, Blinding description: Blinding will be done in the case of participants and the main investigator. For blinding, placebo capsules will be prepared in the same size, shape, bottle with taurine capsules. Bottles will be encoded A or B. Also, the researcher is unaware of the type of capsules. Therefore, that participants and researcher will be blinded at the selection step and information collection. 3 Obesity. Intervention 1: Intervention group: Daily consumption of 3 gram taurine ( cap 1 gram ) simultaneously with weight loss diet for 8 weeks. Intervention 2: Control group: Daily consumption of 3 cap placebo simultaneously with weight loss diet for 8 weeks. Yes - There is a plan to make this available What will be shared: Publication of protocol study in form of the article and also data publication in the original article. The total potential data can be shared after unidentifiable subjects. When: 6 months after the publication of results To whom: All researchers who have access to clinical trials databases Conditions: The only way for using the data is after the publication of the article in the indexed ISI journal. Where to obtain: Via database websites such as PubMed and google scholar and via email address: maryamasadi136@gmail.com How to obtain: The original article reaches the requestor by email within a maximum of one week. Comments:
public Maryam Asadi
Department of Nutrition, Para-Medical School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8253 maryamasadi136@gmail.com Ahvaz Jundishapur University of Medical Sciences scientific Fatemeh Haidari
Department of Nutrition, Para-Medical School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khuzestan, Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8253 haidari58@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 50 years old Body mass index between 30 to 40 18 years 50 years Female Pregnancy and breast feeding Menopause Food allergy Having surgical operation to weight loss Having weight loss over the past six months Consumption of multivitamin/mineral supplements, herbal supplements or weight-loss drugs Having a special diet Having a history of cancer, acute or chronic renal Failure, acute or chronic hepatic failure, thyroid disorder and gastrointestinal diseases E66.0 Obesity due to excess calories, Treatment - Drugs Placebo Intervention group: Daily consumption of 3 gram taurine ( cap 1 gram ) simultaneously with weight loss diet for 8 weeks Control group: Daily consumption of 3 cap placebo simultaneously with weight loss diet for 8 weeks Serum level of fibroblast growth factors FGF19. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of fibroblast growth factors FGF21. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of β-Klotho co-receptor. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of leptin. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of adiponectin. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of High sensitivity C-reactive protein ( hs-CRP). Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Serum level of insulin. Timepoint: Before and 8 months after intervention. Method of measurement: ELISA. Lipid profile. Timepoint: Before and 8 months after intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Alanine transaminase, Aspartate transaminase and Gamma-glutamyltransferase. Timepoint: Before and 8 months after intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Body composition. Timepoint: Before, 4 weeks and 8 weeks after intervention. Method of measurement: Bioelectrical impedance analysis. Waist circumference. Timepoint: Before, 4 weeks and 8 weeks after intervention. Method of measurement: Tape metre. Fasting blood sugar (FBS). Timepoint: Before and 8 months after intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Body weight. Timepoint: Before, 4 weeks and 8 weeks after intervention. Method of measurement: Scale. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Timepoint: Before and 8 months after intervention. Method of measurement: HOMA-IR: [fasting insulin Mu/ml × fasting glucose mg/dl]/405. Ahvaz University of Medical Sciences Approved 2018-11-10 Ethics committee of Ahvaz Jundi shapur University of Medical Sciences Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)