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A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users
Sponsor: AB Mauri (UK) Limited,
Summary
This is a randomized, triple-blind, placebo-controlled, virtual clinical trial evaluating the effects of the Oxxynea® botanical supplement on gut comfort in adults who use GLP-1 receptor agonists (GLP-1 RAs). Seventy participants experiencing gastrointestinal discomfort associated with GLP-1 RA use will be randomized to receive either Oxxynea® or a matching placebo once daily for six weeks. Participants will complete questionnaires at Baseline, daily for the first 14 days, and at the end of Weeks 2, 4, and 6. The primary measure is change in gastrointestinal comfort assessed by the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures include quality of life, participant-perceived product benefits, and specific GI symptom changes (nausea, abdominal pain, bloating, diarrhea, and constipation).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-06-01
Completion Date
2026-10-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Placebo
Participants take one capsule of a matching placebo (maltodextrin 400 mg in a transparent green HPMC capsule, size 0) once daily in the morning with the first meal of the day for six weeks. The placebo is matched to the active product in taste and appearance.
Oxxynea® Supplement
Participants take one capsule of Oxxynea® once daily in the morning with the first meal of the day for six weeks.
Locations (1)
Citruslabs
Las Vegas, Nevada, United States