This study tests the hypothesis that a supplement that combines a functional fiber, long chain omega-3 polyunsaturated fatty acids (PUFAs), vitamin D3, vitamin E, and zinc will reduce clinical symptoms, decrease pro-inflammatory cytokines in the blood and ergo decrease inflammation, promote beneficial microbial activity in the colon, and help recovery of the intestinal mucosa of ulcerative colitis (UC) patients compared with a placebo.
An anticipated 30 participants with newly diagnosed active ulcerative colitis will be recruited to participate in a randomized control trial, with 50% of the subjects distributed to the supplement (n=15) and the other 50% provided a placebo control (n=15). This is considered as a "proof of concept" study to determine if there is evidence that a multi-ingredient supplement (immunonutrition) will reduce UC disease severity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
30
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
rice starch, light olive oil, vegetable oil
GI Specialists Foundation
Memphis, Tennessee, United States
RECRUITINGReduced inflammatory cytokines
cytokines will be isolated from blood analysis
Time frame: 2 months
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
SCFA will be isolated from stool sample. SCFAs are anti-inflammatory components generated in the colon. The SCFAs looked at include acetate, lactate, propionate, butyrate, and isobutyrate.
Time frame: 2 months
Reduced bowel movements per day
Many with Ulcerative colitis can experience 10+ bowel movements per day. This intervention is aiming to reduce the total number of bowel movements per day
Time frame: 2 months
Decreased intestinal cramping/ pain
Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants
Time frame: 2 months
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