NCT07096739

Tolerance of a High Protein Nutrition Shake in Individuals on GLP-1

Tolerance and Acceptance of a High Protein Nutrition Shake in Individuals Treated With the GLP-1 Receptor Agonist Semaglutide: a Single Arm, Open Label Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kate Farms Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.

Detailed description

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

Conditions

• GLP-1 Concentration

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High protein shake	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2025-07-31
• Last updated: 2025-12-09

Locations

1 site across 1 country: Canada