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
Arrae
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 sta…
Interventions
- Dietary SupplementBloat 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 SupplementPlacebo
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.
Location
- Alethios, Inc.San Francisco, California