Comparison of Extra Virgin Olive Oil and Canola Oil on Clinical Outcomes and Inflammatory Markers (hsCRP, TNF-α) among Patients with Ulcerative Colitis(UC)

Comparison of Extra Virgin Olive Oil and Canola Oil on Clinical Outcomes and Inflammatory Markers (hsCRP, TNF-α) among Patients with Ulcerative Colitis(UC)

The present study is a randomized, cross-over, and single-blind phase 2-3 clinical trial, will be carried out on 30 patients with ulcerative colitis, referred to Imam Khomeini Hospital clinic, and Gastrointestinal Specialist confirmed their disease. Patients are randomly divided into two groups, each group uses Extra Virgin Olive oil or Canola oil, in different order. Group 1: First, Extra Virgin Olive oil, then Canola oil, Group 2: First, Canola oil, then Extra Virgin Olive oil. Assignment of patients to each group of the study will be done by random block method using four blocks (based on the weight variable). Sampling will be done in Simple Random Non-probability Sampling way, so that from the start of the study, all patients who have the inclusion criteria and who do not have exclusion criteria will be selected as samples, and this will continue until to achieve final sample size.

The aim of this study is to compare the effect of Extra Virgin Olive oil and Canola oil on inflammatory markers as a complementary treatment in patients with ulcerative colitis at Imam Khomeini Hospital, Ahvaz. This study is Cross-over. Patients are randomly divided into two groups (Extra Virgin Olive Oil/and or Canola oil) and use oils in different order. The type of blindness in this study is single-blind, so that the person who evaluates the outcome of the treatment (data analyst) is not aware of the type of treatment.

Inclusion criteria: Ulcerative colitis, confirmed by histopathology The severity of the disease is mild to moderate Non-infectious, autoimmune and inclusive diseases (including cancer, kidney disease, rheumatoid arthritis, liver, AIDS, and cardiovascular disease) No use of ω3 supplements, fish oil Body mass index ranges from 18.5 to 30 Sex is male The age range is between 18 and 75 years old People's Inclination to collaborate on the plan Exclusion criteria: The patient is in the acute phase of the disease The patient does not tolerate the recommended oils reluctancy to continue cooperation in this research

Cross-over intervention Group 1: First, Extra Virgin Olive oil, then Canola oil, Group 2: First, Canola oil, then Extra Virgin Olive oil

Serum hs-CRP; Serum TNF-α; Serum ESR; Stool frequency per day; Frequency of rectal bleeding per day

Randomization in this study will be done by block method, which means that the researcher divides individuals into subgroups called blocks. The randomization unit in this study is a block and the number of people in each block is similar and four. Assignment of patients to each groups of the treatment will be done by using these blocks. In this method, SAS algorithm software is used to make random sequences and determine the type of treatment assigned to each patient. Concealment will also be done by placing the type of treatment assigned to each person in the envelope, so that the person providing the treatment is unaware.

The type of blindness in our study will be single-blind, so that the person who evaluate the outcomes of the study (data analyzer), does not know the type of treatment assigned to each patient. The type of treatment and its order is characterized by coding. In this study, due to the nature of complementary treatment (Extra Virgin Olive oil and Canola Oil), there is no possibility for blinding participant, clinician and researcher.