A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorArrae
About this trial
The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females aged 18-65 years, inclusive
BMI of 18.5 to 29.9 kg/m2, inclusive
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Disqualifiers
Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)
Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients
Current or history of any significant diseases of the GI tract or digestive disorders (e.g., irritable bowel syndrome, celiac disease, inflammatory bowel disease, functional constipation, gastroesophageal reflux disease, being treated within the past year for H. pylori infection or gastric ulcer), use of medications that inhibit peristaltic movement (e.g., opioids, loperamide), esophageal obstruction, or difficulty swallowing, as assessed by the QI
Trial design
Design model
Parallel
Treatments tested in this trial
Bloat
Dietary supplementParticipants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.
Placebo
Other interventionParticipants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: BloatExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo
The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'.
Time frame
Day 1 to Day 56Secondary outcomes
1
The difference in change in bloating from pre-dose (postprandial) at t = 30 mins post-dose (postprandial) and t = 120 mins post-dose (postprandial) between Bloat and placebo
The difference in change in bloating from pre-dose (postprandial) at t = 30 mins post-dose (postprandial) and t = 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by bloating numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'.
Time frame
Day 1 to Day 562
The difference in change in gas from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo
The difference in change in gas from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by the gas numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'.
Time frame
Day 1 to Day 563
The difference in change in abdominal discomfort from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo
The difference in change in abdominal discomfort from pre-dose (postprandial) at t = 30, 60, and 120 mins post-dose (postprandial) between Bloat and placebo, as assessed by the abdominal discomfort numeric rating scale at screening/baseline. On a scale from 0 to 11, with 0 being 'none' and 10 being 'most I have ever experienced'.
Time frame
Day 1 to Day 564
The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo
The difference in change in GI symptoms from baseline at Day 28 and Day 56 between Bloat and placebo, as assessed by PROMIS-GI Gas and Bloating Scale. All items are administered using a 5-point categorical response scale.
Time frame
Day 1 to 56Other outcomes
1
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Time frame
Day 1 to Day 562
Clinically relevant changes in blood pressure after supplementation
Change in blood pressure (mmHg) after supplementation
Time frame
Day 1 to Day 563
Clinically relevant changes in heart rate after supplementation
Change in heart rate (beats per minute) after supplementation
Time frame
Day 1 to Day 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arrae
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov