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Not Yet RecruitingNCT07516587

Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Safety and Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Arrae · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBloat GummiesParticipants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.
DIETARY_SUPPLEMENTPlaceboParticipants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart.

Timeline

Start date
2026-04-01
Primary completion
2026-06-01
Completion
2026-10-01
First posted
2026-04-08
Last updated
2026-04-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07516587. Inclusion in this directory is not an endorsement.