]>
IRCT20200914048712N1 IRCT 2020-09-15 Tehran University of Medical Sciences The effect of beta-caryophyllin on food addiction of women The effect of beta-caryophyllin supplementation on neuropeptides affecting brain reward axis, mental health, eating behaviour, appetite and body composition in obese women with food addiction 2020-12-21 anticipated 84 Complete https://irct.ir/trial/50928 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To apply randomization, the random blocks method with 4 blocks will be used. According to the sample size of 86 people, 22 blocks of 4 will be produced using the online site (www.sealedenvelope.com). In order to apply concealment in the randomization process, unique codes will be used on the medicine boxes, and the desired code will also be generated by the software. Participants will be entered into the study based on the sequence produced, and medication packages with a registered code will be assigned to the individual. Therefore, before selecting participants, the person will be unaware of the type of treatment she will receive, and also the random sequence generated during the study will be unpredictable, Blinding description: Since this study is a double-blind type, in order to conduct this research in a double-blind manner, at the beginning of the study, the cans containing the relevant capsules are coded in A and B by someone other than the researcher, so that the researcher and participants do not know the type of capsules received. 2-3 food addiction. Intervention 1: Intervention group: Intervention with a dose of 100 mg soft gel beta-caryophylline per day for 2 months, 1 orally daily. The manufacturer is still unknown. Intervention 2: Control group: placebo at a dose of 100 mg per day soft gel containing starch for 2 months every day 1 soft gel. The manufacturer is still unknown. Yes - There is a plan to make this available What will be shared: All data is shareable When: Access period starts from 1401 To whom: Researchers working in academia and people in industry can also apply for the data. Conditions: For research and industrial applications whose ultimate goal is health promotion Where to obtain: Mohammad Hassan Javanbakht tell: 00989123640104 mhjavan2001@yahoo.com How to obtain: By email and communication with the project manager Comments:
public Mohammad Hassan Javanbakht
keshavarz boulevard, Tehran university of medical sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3333 mhjavan2001@yahoo.com Tehran University of Medical Sciences scientific Mohammad Hassan Javanbakht
keshavarz boulevard, Tehran university of medical sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8889 6696 mhjavan2001@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Body mass index between 30 to 99.99 kg/m2 confirmation of food addiction using the relevant questionnaire being in the age range of 18-50 years 18 years 50 years Female Reluctance to continue collaborating with the study Having a weight loss diet in the last two months Menopause Continuous use (more than once a week) of vitamin and mineral supplements in the past month Pregnancy and lactation Consumption of alcohol, cigarettes (more than 3 cigarettes per day for the past 6 months), tobacco or drugs Use of weight loss and appetite suppressants Physical activity started from more than last three weeks History of neurological diseases or use of psychiatric drugs E66 Overweight and obesity Treatment - Drugs Placebo Intervention group: Intervention with a dose of 100 mg soft gel beta-caryophylline per day for 2 months, 1 orally daily. The manufacturer is still unknown. Control group: placebo at a dose of 100 mg per day soft gel containing starch for 2 months every day 1 soft gel. The manufacturer is still unknown. Food addiction. Timepoint: at the baseline and end of study. Method of measurement: Yale Food Addiction Scale (YFAS). Plasma oxytocin. Timepoint: Before and after the study. Method of measurement: ELISA. Plasma neuropeptide Y. Timepoint: Before and after the study. Method of measurement: ELISA. Orexin. Timepoint: Before and after the study. Method of measurement: ELISA. Mental health. Timepoint: Beginning and end of the study. Method of measurement: Stress-Anxiety-Depression Questionnaire (DASS-21). Body composition. Timepoint: At the beginning and end of the study. Method of measurement: body composition analyzer. Appetite. Timepoint: At the beginning and end of the study. Method of measurement: Appetite questionnaire. Tehran University of Medical Sciences Approved 2020-09-10 Ethics Committee of Tehran University of Medical Sciences Tehran, Keshavarz Boulevard, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)