Study protocol
TNF-α
CHRONIC ILLNESSES
After applying the inclusion and exclusion criteria mentioned above, recruited participants were given a full explanation of the study and required procedures and those who agreed to join, signed written consent. Subjects were recruited in three cohorts on Sundays from 08:00–10:00 h, in the period of February and March, 2020. Full history and physical examination were obtained from each participant to rule out any acute or chronic illnesses. Two blood samples were collected from all participants, in the Family and Community Medicine (FAMCO) Center in the IAU campus, before initiation of the study and at the end of the four-week study duration. The first sample was assessed in the center’s laboratory for basic tests which included complete blood count (CBC), renal function test (RFT) and liver function test (LFT) to assure the general health of the participant. The second sample was assessed in the microbiology laboratory in the College of Medicine at IAU to determine baseline cytokines level by enzyme-linked immunosorbent assay (ELISA). A third and fourth blood sample was collected from the last cohort of participants, before and after intervention. The third sample was used to measure CD profile by flow cytometric kits as well as immunoglobulins (IgG, IgM). The fourth blood sample was collected in heparin tubes to evaluate the gene expression profile of IFN-γ, NF-κB, TNF-α, IL-1β, IL-13, IL-8, and IL-6. Participants were followed daily by telephone calls for the whole study period (4 weeks) to ensure taking the capsules. ELISA kits for IL-1, IL-4, IL-6, IL-10, and TNF were bought from Origin company, USA, and the cytokines levels were measured according to the manufacturer recommendation. CD profile was measured using flow cytometric kits (TBNK kit, BD biosciences, USA).The study has been approved by the university ethical board under the reference (IRB-2020-UGS-01-032) and was registered in ISRCTN registry (ISRCTN14150499, 16/11/2020,
