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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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A novel dietary intervention combining a standardized IBD diet (IBD-AID) with supplementation from a pea protein plant-based oral nutrition supplement (ONS) (Kate Farms Peptide 1.5) to improve protein, calorie, and nutrient intake in adult patients experiencing a Crohn's disease flare starting new immunologic therapy. Additionally, this study will include objective measures of body composition to improve nutrition status assessment and provide a more sensitive measure of intervention efficacy compared to anthropometric measures of body weight or BMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD-AID diet | Placebo Comparator |
| |
| IBD-AID Diet + Kate Farms Peptide 1.5 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBD-AID diet combined with Kate Farms Peptide 1.5 | Dietary Supplement | Combining standardized-IBD diet developed by the University of Minnesota (IBD-AID) with commercially available pea protein plant-based enteral nutrition formula (Kate Farms Peptide 1.5) |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrient intake | Nutrient intake improvement assessed by 24-hour dietary recall from a combined intervention of a standard IBD-AID diet with an oral nutrition supplement drink (Kate Farms Peptide 1.5) compared to a standard diet alone without an oral nutrition supplement drink. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body composition measures assessed by bioimpedance spectroscopy (BIS). | 8 weeks |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| IBD-AID diet | Other | Standardized IBD diet developed by the University of Massachusetts Medical School (IBD-AID) |
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