BloatingNCT07370740
A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
A study testing Bloat in people with Bloating and Gastrointestinal Symptoms, run by Arrae at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Bloating, Gastrointestinal Symptoms, Intestinal Gas
- What is being tested?
- Bloat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 19 Aug 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- Intrauterine devices
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- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- 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
Who cannot join
- 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
- Individuals with anemia, gallstones, or gallbladder disease as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
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- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Chronic use of cannabinoid products (>2 times/week) as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past 6 months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the IP (Section 7.3)
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Erin Lewis, PhD, 519-438-9374 x 248, elewis@kgkscience.com
David Crowley, MD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
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.
- Conditions
- Bloating, Gastrointestinal Symptoms, Intestinal Gas
- Being tested
- Bloat, Placebo
- Keywords
- Bloat, Arrae, Bloating, Intestinal Gas, Gastrointestinal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloatDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bloat |
| Placebo | Placebo comparator | Placebo is comprised of white rice flour Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Day 1 to Day 56
Secondary outcomes (8)
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'.
Measured: 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'.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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')
Measured: 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
Measured: Day 1 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start19 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrae
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370740
- Sponsor's protocol ID
- 25ARCCB01
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women
- ClinicalTrials.gov ID
- NCT07370740
- Acronym / sponsor ID
- 25ARCCB01
- Conditions
- Bloating, Gastrointestinal Symptoms, Intestinal Gas
- Keywords
- Bloat, Arrae, Bloating, Intestinal Gas, Gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ArraeIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bloat | Experimental | Dietary Supplement: BloatBloat 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 | Other: PlaceboPlacebo is comprised of white rice flour |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (22 listed)
- 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
- Individuals with anemia, gallstones, or gallbladder disease as assessed by the QI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BloatParticipants 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. | Dietary supplement | Bloat |
| PlaceboParticipants 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. | Other | Placebo |
Primary outcome
The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo
Time frame: Day 1 to Day 56
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'.
8 secondary outcomes
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
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
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
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
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
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
Time frame: Day 1 to 56
The difference in change in gas, bloating, and abdominal distention scores
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
Time frame: Day 1 to Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloat in people with Bloating and Gastrointestinal Symptoms, run by Arrae at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (519-438-9374 x 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo (time frame: Day 1 to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.