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IRCT20190129042552N2 IRCT 2020-05-30 Ahvaz University of Medical Sciences Evaluation of olive leaf extract in obese women on weight-loss diet Evaluation of olive leaf extract on weight and body composition, free fatty acid, glycemic factors, lipid profile and serum level of adipocytokines in obese women on a weight-loss diet 2020-06-21 anticipated 70 Complete https://irct.ir/trial/48092 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 olive leaf extract 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 olive leaf extract 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. N/A Obesity. Intervention 1: Intervention group: Daily intake of 250 mg olive leaf extract as 2 pills and weight loss diet. Intervention 2: Control group: Daily intake of 250 mg placebo as 2 pills and weight loss diet. 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: forough_shayesteh@yahoo.com How to obtain: The original article reaches the request or by email within a maximum of one week. Comments:
public Shayesteh
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 Forough_shayesteh@yahoo.com Ahvaz 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 18-50 years Body mass index 30-40 kg/m2 18 years 50 years Female Menopause Pregnancy and breast feeding Food allergy Having a history of cancer, acute or chronic renal Failure, acute or chronic hepatic failure, thyroid disorder and gastrointestinal diseases 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 Don’t use more than 10% of medications E66.0 Obesity due to excess calories Treatment - Drugs Treatment - Drugs Intervention group: Daily intake of 250 mg olive leaf extract as 2 pills and weight loss diet Control group: Daily intake of 250 mg placebo as 2 pills and weight loss diet Body weight. Timepoint: Before, after 4 and 8 weeks. Method of measurement: Scale. Body composition. Timepoint: Before, 4 weeks and 8 weeks after intervention. Method of measurement: Bioelectrical impedance analysis. Serum level of free fatty acid. Timepoint: Before and 8 weeks after intervention. Method of measurement: ELISA. Fasting blood sugar (FBS). Timepoint: Before and 8 months after intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). 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. Lipid profile. Timepoint: Before and 8 months after intervention. Method of measurement: Colorimetric enzymatic method (Pars Azmun). Serum level of leptin. Timepoint: Before and 8 weeks after intervention. Method of measurement: ELISA. Serum level of adiponectin. Timepoint: Before and 8 weeks after intervention. Method of measurement: ELISA. Ahvaz University of Medical Sciences Approved 2020-05-02 Ethic committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)