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

Part of paid clinical trials in San Francisco, California.

Sponsor
Arrae
Study ID
NCT07516587
Status
Not Yet Recruiting

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Conditions

  • Abdominal Discomfort
  • Digestive Health
  • Gas and Bloating

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Bloat Gummies — DIETARY_SUPPLEMENT
    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.
  • Placebo — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Bloat Gummy
    Bloat is a gummy that contains the active ingredients ginger root extract, lemon balm extract, dandelion root extract and the postbiotic HTES1, Bifidobacterium longum CECT7347.
  • Placebo Comparator: Placebo Gummy
    The placebo is a gummy that looks and tastes like the study gummy, but with no active ingredients.

Primary Outcome Measure

Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo. [ Time Frame: Evaluated from pre-dose to 60 minutes post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Alethios, Inc.San FranciscoCalifornia94109
Alethios
[email protected]
650-206-8006

Find similar trials in San Francisco, CA

By research site
Alethios, Inc.· San Francisco, CA

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