Study to Investigate the Efficacy of a Digestive Health Dietary Supplement on Post-meal Bloating in Healthy Participants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArrae
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 (GERD), gastroparesis, or treatment for H. pylori infection or gastric ulcer within the past year.
Significant or untreated medical and/or psychiatric disorders, including but not limited to: severe unstable diabetes, recent myocardial ischemia or infarction, unstable angina, cancer (except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative or volunteers with cancer in full remission for more than five years after diagnosis are acceptable), uncontrolled hypertension, renal failure, chronic active hepatitis, acute hepatitis, cirrhosis, Acquired Immunodeficiency Syndrome (AIDS), malignancy, and neurological disorders including epilepsy, recent cerebrovascular disease, or recent traumatic brain injury.
Current use of digestive enzyme supplements, prebiotics/fibers, probiotics, postbiotics, bloating-targeted supplements, therapeutic iron supplementation (>65 mg elemental iron per dose), prokinetic agents, antacids, H2 blockers, proton pump inhibitors (PPIs), opioids, or loperamide within 14 days prior to the first test meal session; or use of any of the above during the study period.
Esophageal obstruction or difficulty swallowing.
Trial design
Design model
Crossover
Treatments tested in this trial
Bloat Gummies
Dietary supplementParticipants 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 supplementParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Bloat GummyExperimental treatment 1 intervention
Group B: Placebo GummyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-doseSecondary outcomes
1
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-dose2
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.3
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.4
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. Source ClinicalTrials.gov
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