Effect of a Nutrition Support Formula in Adults With Inflammatory Bowel Disease: A Pilot Study
Abstract
BACKGROUND: Due to the high prevalence of nutrient deficiencies in patients with inflammatory bowel disease (IBD), routine monitoring of nutrient status and supplementation are recommended.
OBJECTIVE: This preliminary study was implemented to prospectively identify potential effects of a nutrition support formula on blood nutrient parameters in adults with IBD.
METHODS: Ten adults with Crohn's disease or ulcerative colitis were recruited from the Portland, Oregon, metropolitan area into a single-arm, open-label pilot study. Participants consumed a nutrition support beverage twice daily for 12 weeks. The formula contained a mixture of micronutrients (including methylated forms of folate and vitamin B12), macronutrients, and phytonutrients (including curcumin, xanthohumol, ginger compounds, and quercetin). Primary measures were the following parameters: folate, vitamin B12, red blood cell (RBC) count, hemoglobin, hematocrit, electrolytes, and albumin. Exploratory measures included a food frequency questionnaire, circulating blood cell counts, and inflammatory markers.
RESULTS: Nine participants completed the study and one withdrew. Adherence was 98%. Serum folate increased 48.7% (P = .029), serum vitamin B12 increased 17.4% but did not reach statistical significance (P = .053), and red cell distribution width (RDW) decreased 9.2% (P = .012) over the 12-week study period. There were minimal shifts in total white blood cell (WBC) counts (-1.0%, P = .845), but percent neutrophils…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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