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IRCT20150304021342N2 IRCT 2020-05-23 Esfahan University of Medical Sciences Effect of low-fat, low-carb and high-protein diet in ulcerative colitis The effects of dietary modification programme (low-fat, low-carb and high-protein diet) on mood status, fatigue and quality of life in patients with ulcerative colitis 2019-11-22 anticipated 80 Complete https://irct.ir/trial/47717 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A blocked randomization method with randomly permuted blocks sizes 4 was used to assign each patients to an intervention or control group, to guarantee recruitment balance between the 2 groups and avoid possible risk for selection bias. Depending on age and gender, individuals are placed in blocks of four and are placed in one of the intervention and control groups using a table of random numbers. N/A Ulcerative colitis. Intervention 1: Intervention group: Patients who were assigned to the intervention group participated in a 3-months dietitian-led dietary modification programme (low-fat, low-carb and high-protein diet). Participants were provided dietary guidelines in the form of an educational booklet and dedicated diet. The dietary guidelines of dietary modification programme primarily focused on the reduction of ulcerative colitis symptoms and nutritional deficiency risks. The provided guidelines endeavored to consolidate the existing documents as well as existing guidelines on diet and ulcerative colitis. The dietary modification programme consisted of recommendation that participants eat often and little (4-6 times per day), consume foods at a balanced temperature, decrease consumption of spicy foods, decrease excess intake of fat, decrease simple carbohydrate and drink adequate fluids. Moreover, increase good quality protein and eliminate dairy products in the presence of lactose intolerance. Furthermore, it included avoidance of margarine, limiting alcohol, caffeine and commercially prepared foods including fast foods, ready meals and canned foods. Intervention 2: Control group: Patients randomized to the control group received routine care at the inflammatory bowel disease center. Usual dietary advice included general oral and written information about healthy food choices based on the Healthy Eating Plate with 50–60% carbohydrates, 15–20% protein and 30% total fat. This composition was more parallel to the Iranian dietary pattern. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: Babak Tamizifar How to obtain: The data will send as soon as possible, after receiving the request Comments:
public Babak Tamizifar
Hezarjrib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 btamizi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Babak Tamizifar
Depart. of G.I, Alzahra University hopspital, Sofe BLVD
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 5555 tamizib@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Aged 18–80 years Confirmed diagnosis of ulcerative colitis by gastroenterologist 18 years 80 years Both Subjects with dose changes of azathioprine, mercaptopurine, methotrexate, or biologics in the preceding 12 weeks Consumption of probiotics, prebiotics or following especial diet in the preceding 8 weeks K51 Ulcerative colitis Treatment - Other Placebo Intervention group: Patients who were assigned to the intervention group participated in a 3-months dietitian-led dietary modification programme (low-fat, low-carb and high-protein diet). Participants were provided dietary guidelines in the form of an educational booklet and dedicated diet. The dietary guidelines of dietary modification programme primarily focused on the reduction of ulcerative colitis symptoms and nutritional deficiency risks. The provided guidelines endeavored to consolidate the existing documents as well as existing guidelines on diet and ulcerative colitis. The dietary modification programme consisted of recommendation that participants eat often and little (4-6 times per day), consume foods at a balanced temperature, decrease consumption of spicy foods, decrease excess intake of fat, decrease simple carbohydrate and drink adequate fluids. Moreover, increase good quality protein and eliminate dairy products in the presence of lactose intolerance. Furthermore, it included avoidance of margarine, limiting alcohol, caffeine and commercially prepared foods including fast foods, ready meals and canned foods. Control group: Patients randomized to the control group received routine care at the inflammatory bowel disease center. Usual dietary advice included general oral and written information about healthy food choices based on the Healthy Eating Plate with 50–60% carbohydrates, 15–20% protein and 30% total fat. This composition was more parallel to the Iranian dietary pattern. Mood status. Timepoint: At baseline and after 12 weeks. Method of measurement: Depression, Anxiety, Stress-21 questionnaire. Fatigue. Timepoint: At baseline and after 12 weeks. Method of measurement: Fatigue Severity Scale. Quality of life. Timepoint: At baseline and after 12 weeks. Method of measurement: 36-Item Short Form Survey. Lipid profile. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Esfahan University of Medical Sciences Approved 2018-06-11 Ethics committee of Isfahan University of Medical Sciences Hezarjrib street Isfahan Isfehan Iran (Islamic Republic of)