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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197413
• Other study ID #: 20219Arrae
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Arrae
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Heartburn
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Arrae bloat supplement
The supplement contains organic dandelion root extract, organic lemon balm herb top extract, organic peppermint leaf extract, organic bromelain, organic slippery elm inner bark extract. The capsule itself is made of cellulose, which is not a main active ingredient.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Arrae	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in IBS symptoms (bloating, heartburn and gas)	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.	4 weeks
Primary	Reduction in anxiety symptoms	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.	8 weeks