Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms

Not Applicable

Completed

• Conditions: Anxiety; IBS - Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Arrae bloat supplement

• Registration Number: NCT05197413
• Lead Sponsor: Arrae

Brief Summary

This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).

Detailed Description

It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve subjective wellbeing in trial participants. It is further hypothesized that a second dietary supplement marketed as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Female over 18 years old
• Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals
• Must be in good health (don't report any medical conditions asked in the screening questionnaire)
• Following a stable, consistent diet regimen
• Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study
• May have self-reported sleep issues
• May have self-reported mild anxiety/depression
• May have self-reported occasional panic attacks

Exclusion Criteria

• Prior prescriptions for IBS
• Current IBS treatment (e.g. proton pump inhibitors, laxatives)
• Follow an extreme diet intervention
• Experienced severe weight loss in the past 3 months prior to study participation
• Antibiotic usage within 3 months prior of study participation
• Usage any medication or herbal remedies which can affect the GI tract
• Food intolerances/allergies
• Pineapple sensitivity/allergy
• Taking cortisol lowering prescription medication
• Has any of the following medical conditions:

History of GI tract cancers Celiac disease / gluten intolerance GI bleeding Rectal bleeding Heme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate to severe depression/anxiety Moderate to severe panic attacks

• Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arrae Bloat supplement	Arrae bloat supplement	The "Bloat" capsules are a blend of 5 herbs and a fruit-based digestive enzyme that target the cause for IBS symptoms.

Primary Outcome Measures

Name	Time	Method
Reduction in IBS symptoms (bloating, heartburn and gas)	4 weeks	Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in IBS symptoms between baseline and study intervention period.
Reduction in anxiety symptoms	8 weeks	Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in anxiety symptoms between baseline and study intervention period.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States