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| Name | Class |
|---|---|
| California Table Grape Commission | OTHER |
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The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).
This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).
The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease (CD).
An 28 day pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table
Participation in this study will last for a maximum of 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze-dried Grape powder intervention | Experimental | participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze dried grape powder | Dietary Supplement | 46g/d freeze-dried grape powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| fecal microbiota composition | 16S microbiome | baseline (pre-intervention), immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| fecal myleoperoxidase (MPO) | fecal marker of inflammation | baseline (pre-intervention), immediately after the intervention |
| fecal calprotectin | fecal marker of inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abigail Basson, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42356234 | Derived | Eftekhar MS, Singh D, Katz J, Nguyen V, Menghini P, Rodriguez-Palacios A, Cominelli F, Raffner Basson A. Effect of Short-Term Grape Powder Supplementation in Patients with Crohn's Disease: A Pilot Study. Nutrients. 2026 Jun 8;18(12):1844. doi: 10.3390/nu18121844. |
| Label | URL |
|---|---|
| California Table Grape Commission | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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subjects will continue to consume their usual diet (excluding all grapes/berries) and consume 46g/d freeze-dried grape powder daily (consumed as 22.5g packets twice daily for 21 days. A stool and blood sample will be collected at the start and end of the intervention.
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| baseline (pre-intervention), immediately after the intervention |
| C-reactive protein (CRP) | blood marker of inflammation | baseline (pre-intervention), immediately after the intervention |
| D007410 | Intestinal Diseases |