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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Participants 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.
Participants 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.
KGK Science Inc.
London, Ontario, Canada
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 56
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 56
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 56
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 56
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 56
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 Reflux Scale. All items are administered using a 5-point categorical response scale.
Time frame: Day 1 to 56
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 Belly Pain Scale. All items are administered using a 5-point categorical response scale.
Time frame: Day 1 to 56
The difference in change in gas, bloating, and abdominal distention scores
The difference in change in gas, bloating, and abdominal distention scores as assessed weekly by the gas, bloating, and abdominal distension numeric rating scales. Participants will be instructed to complete 11-point numeric rating scales from 0 ('none') to 10 ('most I have ever experienced')
Time frame: Day 1 to Day 56
The difference in change in waist circumference from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo
The difference in change in waist circumference from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo at screening/baseline
Time frame: Day 1 to Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.