Action of Curcuma Longa and Piperine on the oxidative and inflammatory profile of patients with Inflammatory Bowel Disease: a randomized, double-blind, placebo-controlled study

INTERVENTION: This is a double‐blind randomized clinical trial. The randomization process of the participants took place through the “runif” command of the “R” software (v. 4.1.3, The R Project Team, Vienna, Austria). A sequence of 60 random numbers between 0 and 2 was requested to generate the list with a random sequence. This list was under the guard of a researcher without contact with the participants who will be sequentially included, to guarantee the secrecy of the allocation. By simple rounding of the generated random numbers, participants assigned the number “0” were placed in the control group, those assigned the number “1” in the experimental curcumin group, and those assigned the number “2” in the experimental curcumin group. + piperine. Thus, the following were initially included in the study: 19 participants in the Placebo group (who received starch+yellow dye capsules), 20 participants in the curcumin group (who received curcumin extract ‐ in gastro‐resistant capsule ‐ 1g/day) and 19 patients were allocated in the curcumin+piperine group (who received curcumin and piperine extract at a dosage of 1g/day of curcumin + 10mg of piperine); All participants were instructed to take two capsules (500 mg, daily after lunch, for three months CONDITION: Inflammatory Bowel Disease PRIMARY OUTCOME: Expected Outcome 1 ‐ It is expected to find improved antioxidant activity (reduction of lipid peroxidation ‐ malonaldehyde levels (MDA) and oxidized glutathione (GSSG) ‐ increased antioxidant activity ‐ superoxide dismutase (SOD), reduced glutathione (GSH), and reduced inflammatory activity (tumor necrosis factor alpha (TNF?) and interleukins (IL)) Outcome found 1 ‐ It was noticed that there were no changes in the inflammatory profile (fecal calprotectin, TNFa and IL) after supplementation with curcumin and curcumin+piperine. Regarding oxidative stress, the group supplemented with curcumin+piperine had an increase in SOD activity (p<0.05) compared to the placebo group. SECONDARY OUTCOME: Expected outcome 2 ‐ It was expected to find improvement in gastrointestinal complaints, such as nausea, vomiting, diarrhea, constipation, etc. INCLUSION CRITERIA: Patients diagnosed with IBD (Crohn's Disease, Ulcerative Colitis or Unclassified Colitis) of mild to moderate intensity; age equal to or greater than 18 years and up to 80 years; Patients using conventional drug therapy for IBD (aminosalicylates, immunosuppressants, biological); Function preserved kidney and liver