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| Name | Class |
|---|---|
| INQUIS Clinical Research | INDUSTRY |
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Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.
This study investigates the tolerability of a shake specifically designed to reduce GI side effects in individuals being treated with the GLP-1 agonist semaglutide. The study uses a single-arm, open label design where subjects will consume the study product daily for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5 and 7 during the intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Subjects will consume the study product daily for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High protein shake | Dietary Supplement | Subjects in this study will consume the study product for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5, and 7 during the intervention. On the first day, overnight fasted participants will be given the product and symptoms will be followed for 2h. 24h dietary recalls will be collected at the beginning and end of the 7-day treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite GI symptoms score (CSS) | Comparison of the composite GI symptom scores (CSS) recorded during the 7day intervention period with those recorded during the 3-day baseline period. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inquis Clinical Research | Toronto | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42388893 | Derived | Withrow NA, Hsueh EE, Wolever T, Jenkins AL, Campbell J, Zurbau A, McMahon R, Valentine CJ. Plant-Based Nutrition Alleviates Gastrointestinal Symptoms and Enhances Protein Intake during GLP-1 Therapy. Curr Dev Nutr. 2026 Jun 8;10(7):109393. doi: 10.1016/j.cdnut.2026.109393. eCollection 2026 Jul. |
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