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

NCT07516587 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-13

No results posted yet for this study

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

  • Digestive Health
  • Abdominal Discomfort
  • Gas and Bloating

Interventions

DIETARY_SUPPLEMENT

Bloat Gummies

Participants 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_SUPPLEMENT

Placebo

Participants 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.

Sponsors & Collaborators

  • Arrae

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516587 on ClinicalTrials.gov