Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating … (NCT07516587) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants
United States100 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Healthy male and female individuals aged 18-65 years at time of screening.
* Body mass index (BMI) \<29.9 kg/m².
* Self-reported recurrent postprandial abdominal bloating and/or distension occurring on average at least 2 days per week over the past 3 months, predominating over other gastrointestinal (GI) symptoms, and in the absence of a diagnosed gastrointestinal disease.
* Females of child-bearing potential must have a negative baseline pregnancy test and agree to use a medically approved method of birth control for the duration of the study.
* Willing to consume a standardized test meal consisting of 2 slices of large cheese pizza from Dominos on each test day.
* Willing to complete online surveys and at-home measurements (waist circumference) at scheduled time points.
* Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study.
* Provides voluntary, written, informed consent to participate in the study prior to any study procedures.
* Has reliable access to internet and a smartphone or computer capable of completing electronic surveys and attending virtual check-ins.
Exclusion Criteria:
* Current or past diagnosis of any significant disease of the GI tract, including but not limited to: irritable bowel syndrome (IBS), celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), functional constipation, gastroesophageal reflux disease (G…
What they're measuring
1
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.
Timeframe: Evaluated from pre-dose to 60 minutes post-dose