2. Methods
gastrointestinal surgery, overweight or first-class obese
THYROID DISORDERS, RECRUITMENT, DISEASES, IMMUNE SYSTEM DISEASES
The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial to be conducted at the occupational clinical of King Saud University Medical City, Riyadh, Saudi Arabia. Recruitment of subjects will be opened for all students and employees who from King Saud University. The study link will be sent to their email, also they can scan the study code from the banners which are in the active areas at the hospital. A total of 90 overweight or first-class obese subjects, males and females will be recruited and divided equally into 2 groups, a probiotics group, and a placebo group. To be included, a participant should be an adult male or females aged between 19 to 40 years with body mass index (BMI) from 25 to 35 kg/mSubjects who suffer from diseases and are on treatment, such as immune system diseases or thyroid disorders, pregnant women or who plan to be pregnant, those who had gastrointestinal surgery, hormone replacement therapy, on antibiotics and those who consume probiotic or prebiotic supplements regularly will be excluded. Figure Schematic diagram illustrated the methodology.The study has been approved by the Institutional Review Board of the College of Medicine in King Saud University (IRB E-20-5503). The study has also been registered in the Saudi Food and Drug Administration registry (SCTR number 21070702) as well as the US clinical trials registry (ClinicalTrials.gov Identifier: NCT05667038).