Bloat for Abdominal Bloating

MM
Overseen ByMarc Moulin, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of a new supplement called Bloat, which contains natural ingredients like ginger and peppermint, to determine if it can reduce gas and bloating in women. Participants will take either the Bloat supplement or a placebo (a harmless pill with no active ingredients) and report their symptoms after eating a specific meal. The trial seeks women who experience significant gas and bloating at least once a week, especially after meals. Participants must be healthy and agree to maintain their current lifestyle habits during the study. As an unphased trial, this study allows participants to contribute to early research on natural remedies for digestive discomfort.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ingredients in Bloat, such as ginger root extract and bromelain, have been safely used in other digestive products. These ingredients help relieve bloating and gas. For instance, studies have shown that Bloat can reduce bloating by 86% and often works within an hour.

Although specific data from past trials about side effects is lacking, the use of natural ingredients like peppermint and dandelion root suggests it is generally well-tolerated. This clinical trial focuses on safety and effectiveness to confirm these findings. The trial phase is marked as "Not Applicable," indicating a focus on understanding safety rather than testing a new drug. This usually suggests that the treatment is considered relatively safe based on existing knowledge.12345

Why are researchers excited about this trial?

"Bloat" is unique because it combines natural extracts like ginger root, bromelain, and peppermint leaf in one formula specifically targeting abdominal bloating. Unlike standard treatments that often involve antacids or over-the-counter medications for gas relief, Bloat taps into the natural anti-inflammatory and digestive properties of these extracts. Researchers are excited about Bloat because it offers a holistic approach, potentially providing relief with fewer side effects by leveraging these natural ingredients. This novel combination stands out as it aims to address the root causes of bloating rather than just the symptoms.

What evidence suggests that Bloat might be an effective treatment for gas and bloating?

Research has shown that Bloat, a blend of natural ingredients like ginger, bromelain, peppermint, dandelion, lemon balm, and slippery elm, effectively reduces bloating. In this trial, participants will receive either Bloat or a placebo. Previous studies found that Bloat can decrease bloating by 86%. This treatment works quickly, often easing symptoms within an hour. It also helps with other issues related to irritable bowel syndrome (IBS), such as excess gas. Bloat's natural ingredients support digestion and relieve discomfort.24678

Who Is on the Research Team?

DC

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy women experiencing abdominal bloating, gas, and related gastrointestinal symptoms. Participants should be willing to consume a dose of the study medication or placebo and complete questionnaires about their symptoms.

Inclusion Criteria

Agrees to maintain current lifestyle habits as much as possible throughout the study
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
Provided voluntary, written, informed consent to participate in the study
See 5 more

Exclusion Criteria

I have diabetes.
Individuals with an autoimmune disease or are immune compromised
Chronic use of cannabinoid products
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one dose of Bloat or Placebo and answer questionnaires on gas and bloating

8 weeks
Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bloat
  • Placebo

Trial Overview

The trial is testing 'Bloat,' a treatment aimed at reducing gas and bloating. Women will take either Bloat or a placebo, with effects measured using a Gas and Bloating Likert scale one hour after dosing compared to before taking the medicine.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BloatExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arrae

Lead Sponsor

Trials
1
Recruited
40+

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

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Say goodbye to belly bloat and take charge of your digestion*; Bye-bye bloat. Fast-acting relief*; Speed up food breakdown* ...

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Within 1 hour: Experience immediate relief from bloating with the help of Arrae's "Bloat" Digestive Enzymes Supplement, a perfect choice for women's gut health.

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Works within 1 hour for immediate relief; Clinically proven to reduce bloating by 86%; Relieves all IBS symptoms by 74%; Reduces face puffiness and water ...

Arrae - Bloat: Digestive Support - 40 Capsules (20 Servings)

Take 2 Bloat capsules after a meal or whenever you feel bloated. Whether you've had an indulgent dinner or need overall digestive relief, we've ...