Ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: Patients will be advised to replace their daily consumption of sugar and sugar cubes with stevia-containing sweetener cubes (Billo brand), in addition to their usua
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histopathological diagnosis of UC; diagnosis is determined by a gastroenterologist based on laboratory findings and clinical judgment Age=18 years of both sexes Daily intake of at least 1 unit of simple sugars; including sugar cubes and sugar used as sweeteners
Exclusion criteria
Exclusion criteria: Allergy to plants of the Asteraceae/Compositae family (including Ambrosia, chrysanthemum, marigold, chamomile, and others). However, according to a review article, no allergic reactions to stevia have been reported Patients with hypotension or those using antihypertensive medications (including patients taking vasodilators, particularly calcium channel blockers), as some human and animal studies have shown that stevioside reduces both systolic and diastolic blood pressure Patients with hypoglycemia or those using glucose-lowering medications or insulin, since various human and animal studies have demonstrated that stevioside decreases blood glucose levels Patients using statins or other drugs affecting lipid profiles, because these agents alter lipid factor levels independently of the study protocol and may cause false-positive results during the intervention Patients with renal dysfunction or other kidney diseases, as animal studies have indicated that high doses of stevia affect renal activity, perfusion, sodium excretion, and urine flow Patients undergoing cancer treatment, due to the unknown interactions between anticancer drugs and stevia. Although in vitro studies have shown that isosteviol, a component of stevia, inhibits the growth of human cancer cells Presence of other inflammatory or autoimmune diseases, or other conditions affecting inflammatory biomarkers (including common cold, COVID-19, or other viral, bacterial, or parasitic infections) that alter biomarker levels independently of the study protocol Changes in the type and dosage of medications, including corticosteroids, immunosuppressants (such as azathioprine, 6-mercaptopurine, methotrexate), and anti-TNF-a drugs (such as adalimumab and infliximab), as well as alterations in intake of supplements affecting inflammation, including omega-3 fatty acids, polyphenols such as curcumin, probiotic supplements, herbal products, and other antioxidant supplements, all of which can change inflammatory biomarker levels independently of the intervention Pregnancy or lactation, since there is insufficient evidence regarding safety during these periods; although animal studies reported that stevioside at a dose of 2.5 g/kg body weight per day did not affect growth or reproduction Changes in smoking, alcohol consumption, or other factors influencing inflammation during the study period. Patients attending their first visit and who have not previously received any intervention for their colitis; since initiation of treatment in these individuals may cause significant improvement in the measured parameters Adherence to specific dietary regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simple Clinical Colitis Activity Index. Timepoint: At weeks 0, 6. Method of measurement: The Simple Clinical Colitis Activity Index (SCCAI) questionnaire.;Faecal Calprotectin. Timepoint: At weeks 0, 6. Method of measurement: Enzymatic method, micgr/gr.;C-reactive protein. Timepoint: At weeks 0, 6. Method of measurement: Enzymatic method, mg/L.;Lipid profile(Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol-Triglyceride). Timepoint: At weeks 0, 6. Method of measurement: Enzymatic method, mg/dl.;Homeostasis model assessment-insulin resistance. Timepoint: At weeks 0, 6. Method of measurement: HOMA-IR = [ (Fasting Serum Glucose, mmol/L) × Fasting Serum Insulin, µIU/mL) ] / 22.5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: At weeks 0, 6. Method of measurement: Scale. kg.;Body mass index. Timepoint: At weeks 0, 6. Method of measurement: Weight(kg)/[height(m)]2 , kg/m2. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Alizadeh
Oroumia University of Medical Sciences
Outcome results
None listed