Effect of a Comprehensive Nutrition Support Product on the Nutritional Status of Adults With Inflammatory Bowel Disease
Completed · Not applicable
Conditions studied: Colitis, Ulcerative, Crohn's Disease
In brief
Individuals with IBD are at risk for nutrient deficiencies. This prospective, non-randomized, open-label study will assess the effect of a nutrition support product on nutritional status in adults with IBD. Up to ten adults with ulcerative colitis or Crohn's disease will be enrolled in the study and asked to take the product for 12 weeks. The primary measures of the study are several blood markers of nutritional status.
Key facts
- Study ID
- NCT02801240
- Run by
- National University of Natural Medicine
- People needed
- 10
- Starts
- 2016-06-01
- Expected to finish
- 2016-12-16
- Last updated by the study team
- 2018-03-14
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- National University of Natural Medicine — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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