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

Determining the effect of beta-caryophyllin supplementation on neuropeptides affecting brain reward axis, mental health, eating behavior, appetite and body composition in obese women with food addiction

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 84 patients. Excel software rand function was used for randomization.

First, by installing announcements, people at the community will be invited to participate in the study. Then , the subjects will be divided to 3 groups in which obese women with food addiction (first group = 28 people) and obese women without food addiction (second group = 28 people) will be treated with beta-cariophylline at a dose of 100 mg per day for 2 months. The third group (28 people) includes obese women with food addiction who will receive a placebo.

Inclusion criteria: Obese women with 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 Exclusion criteria: Reluctance to continue collaborating with the study, having a weight loss diet in the last two months, pregnancy and lactation, menopause, continuous use (more than once a week) of vitamin and mineral supplements in the past month, 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

Obese women with food addiction (first group = 28 people), obese women without food addiction (second group = 28 people), The third group (28 people) includes obese women with food addiction who will receive a placebo.

Eating behavior

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.

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.

All data is shareable

Access period starts from 1401

Researchers working in academia and people in industry can also apply for the data.

For research and industrial applications whose ultimate goal is health promotion

Mohammad Hassan Javanbakht tell: 00989123640104 mhjavan2001@yahoo.com

By email and communication with the project manager