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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
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.
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.
Alethios, Inc.
San Francisco, California, United States
Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo.
Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Time frame: Evaluated from pre-dose to 60 minutes post-dose
Mean change in bloating severity from pre-dose to t = 30 minutes post-dose, comparing active product vs placebo.
Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Time frame: Evaluated from pre-dose to 30 minutes post-dose
Mean change in gas severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Gas severity will be assessed by a Gas Likert scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in abdominal discomfort severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo.
Abdominal discomfort assessed by abdominal discomfort Likert Scale, of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms."
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Mean change in waist circumference from pre-dose to t = 30 and t = 60 minutes post-dose, comparing active product vs. placebo.
Abdominal distension assessed by mean change in waist circumference measurement.
Time frame: Evaluated from pre-dose to 30 and 60 minutes post-dose.
Proportion of participants demonstrating a reduction in waist circumference.
Abdominal distension assessed by mean change in waist circumference measurement.
Time frame: Evaluated at 30 minutes, 60 minutes or both timepoints post-dose.
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