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COMPLETED
NCT07898189
NA

A Study to Evaluate the Effects of a Supplement on Gut Comfort in GLP-1 Receptor Agonist Users

Sponsor: AB Mauri (UK) Limited,

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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