Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease

It is estimated that 1-1.3 million people in the United States suffer from the Inflammatory
Bowel Diseases (IBD) Crohn's disease (CD) and Ulcerative colitis (UC). The pathophysiology of
IBD involves malnutrition, malabsorption, altered intestinal permeability, inflammation, and
gut flora alterations. Individuals with IBD are at risk for nutrient deficiencies due to
decreased intake, decreased absorption and/or increased enteral losses. The most common
deficiencies involve many micronutrients including vitamins and minerals; less commonly,
adults may also be at risk for macronutrient deficiencies involving protein and total energy
intake. The product being studied is a comprehensive nutrition support product that was
formulated to meet the nutritional needs of individuals with digestive complaints. This study
will assess the effect of the study product on blood markers of nutritional status in adults
with IBD.

Inclusion Criteria:

- Age 18-70

- Ulcerative colitis or Crohn's disease (currently active/not considered in remission)

- Willing to have blood drawn twice and willing to fast for 10-12 hours before blood
draws

- Able to speak, read and understand English

Exclusion Criteria:

- Currently taking a nutrition support product (macronutrient/micronutrient support
product consumed as a reconstituted beverage) or was taken within the last 28 days

- Currently receiving intravenous nutrition support therapy (or within the last 28 days)

- Currently taking curcumin, turmeric, fenugreek, hops, rosemary, ginger or quercetin
(or they were taken within the last 14 days)

- Currently taking anti-coagulant or anti-platelet prescription medications (or they
were taken within the last 28 days)

- Currently taking antibiotic, antiparasitic, or antifungal medications orally or
intravenously (or they were taken within the last 28 days)

- Initiation of or changes to supplements or medications within 28 days prior to
screening

- Initiation of or changes to an exercise regimen within 28 days prior to screening

- Initiation of or changes to a food plan within 28 days prior to screening

- Current involvement or within 28 days prior to screening of a significant diet or
weight loss program

- Hospitalization (for any reason other than a scheduled medical procedure) within 3
months prior to screening

- Gastrointestinal surgery within 3 months prior to screening

- Currently have a colostomy or ileostomy bag in place

- Malignancy within the last 5 years (with the exception of basal cell carcinoma,
squamous cell carcinoma, and/or carcinoma in situ of the cervix)

- Women who are lactating, pregnant or planning pregnancy within the next four months

- Difficulty or aversion to taking powdered drink mixes or nutritional shakes

- Currently participating in another interventional research study or participated in
another interventional study within the previous 28 days