Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bloat | Experimental | Bloat is comprised of a novel combination of ginger root extract, bromelain, peppermint leaf extract, dandelion root extract, lemon balm herb top extract, and slippery elm inner bark extract. |
|
| Placebo | Placebo Comparator | Placebo is comprised of white rice flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloat | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Day 1 to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Day 1 to Day 56 |
| Clinically relevant changes in blood pressure after supplementation | Change in blood pressure (mmHg) after supplementation |
Inclusion Criteria:
Females aged 18-65 years, inclusive
BMI of 18.5 to 29.9 kg/m2, inclusive
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of 3 months. Acceptable methods of birth control include:
Recurrent bloating and/or distension occurring on average at least one day per week which predominates over other GI symptoms in the previous three months, as assessed by the QI
Experiences significant bloating after consumption of the standardized meal provided at screening/baseline, as assessed by a score of ≤ 2 pre-meal and a score of ≥ 5 post-meal
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history as assessed by QI
Exclusion Criteria:
Female
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Moulin, PhD | Contact | 2267819094 | mmoulin@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
Not provided
| ID | Term |
|---|---|
| D011060 | Poloxalene |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | 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. |
|
| 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'. | 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'. | 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. | 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. | 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. | 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') | 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 | Day 1 to Day 56 |
| Day 1 to Day 56 |
| Clinically relevant changes in heart rate after supplementation | Change in heart rate (beats per minute) after supplementation | Day 1 to Day 56 |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |