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NOT YET RECRUITING
NCT07370740
NA

A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

Sponsor: Arrae

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-06

Completion Date

2026-10

Last Updated

2026-07-07

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Bloat

Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.

OTHER

Placebo

Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.

Locations (1)

KGK Science Inc.

London, Ontario, Canada