The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
38
Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.
Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.
University of Miami
Miami, Florida, United States
Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).
sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.
Time frame: Baseline, 4 weeks
Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.
FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.
Time frame: Baseline, 4 weeks
Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.
SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.
Time frame: Baseline, 4 weeks
Change in the expression of inflammatory markers in the colon.
Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.
Time frame: Baseline, 4 weeks
Change in the expression of cytokine in the colon.
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.
Time frame: Baseline, 4 weeks
Change in intestinal microbiota
Change in relative abundance of the microbial communities evaluated as a percentage.
Time frame: Baseline, 4 weeks
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Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score
The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms.
Time frame: Baseline, 4 weeks
Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)
SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms.
Time frame: Baseline, 4 weeks
Rate of adherence to fat intake
Adherence to fat intake is measured by the web-based daily food diary software Nutrihand.
Time frame: Baseline, 4 weeks
Rate of adherence to diet items
Adherence to diet items is measured by the web-based daily food diary software Nutrihand.
Time frame: Baseline, 4 weeks