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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Support Product | Experimental | Participants will be asked to take a nutrition support product twice per day for a period of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition support product | Other | Nutrition support product contains macronutrients, micronutrients, phytonutrients, prebiotics, and glutamine. Product is in powder form and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall nutritional status | The effect on overall nutritional status will be determined by aggregating data from multiple measures (albumin, red blood cell count, hemoglobin, hematocrit, vitamin B12, folate, sodium, potassium and calcium) into one reported value. The proportion (percentage) of abnormal values present at baseline will be calculated and compared to the proportion of abnormal values present at the end of the study. Mean change, pre-to-post treatment, will also be assessed for each individual measure. | Baseline, 12 weeks |
| Albumin, serum | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Red blood cell count | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Hemoglobin | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Hematocrit | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Vitamin B12, serum | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Folate, serum | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer J Ryan, ND, MS | National University of Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Natural Medicine | Portland | Oregon | 97201 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Sodium, serum |
Mean change, pre-to-post treatment, will be assessed. |
| Baseline, 12 weeks |
| Potassium, serum | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| Calcium, serum | Mean change, pre-to-post treatment, will be assessed. | Baseline, 12 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |