A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.

Not Applicable

Completed

• Conditions: Digestion; Digestive Health
• Interventions: Dietary Supplement: Bye Bye Bloat Capsules

• Registration Number: NCT06516744
• Lead Sponsor: Love Wellness

Brief Summary

This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Primary Completion: 2024-04-20
• Study Completion: 2024-04-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women aged 18+
• Self-reported concerns with bloating after eating
• Issues with hormonal bloating
• Generally healthy without uncontrolled chronic diseases
• Willing to avoid using digestive health remedies and other oral supplements during the study

Exclusion Criteria

• Pre-existing chronic conditions preventing adherence to the protocol
• Undergoing procedures related to digestive health
• Started new medications or supplements targeting digestive health in the past 3 months
• Severe allergic reactions requiring an Epi-Pen
• Pregnant, breastfeeding, or attempting to conceive
• Unwilling to follow the study protocol
• Recent surgeries or planned surgeries during the study
• Diagnosed gastrointestinal disorders
• Recent changes in hormonal birth control use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bye Bye Bloat Capsules	Bye Bye Bloat Capsules	Participants will take 2 Bye Bye Bloat capsules immediately after eating (when they feel full and bloated) at least 3 times a week. They may also take the product during times of hormonal bloating. The study will last for 4 weeks, with questionnaires and waist measurements completed at Baseline, first use, Week 2, and Week 4.

Primary Outcome Measures

Name	Time	Method
Reduction in Bloating	Baseline, first use, Week 2, and Week 4	Evaluation of parameters associated with hormonal and food-related bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4.

Secondary Outcome Measures

Name	Time	Method
Improvement in Digestion and Mental Well-being	Baseline, first use, Week 2, and Week 4	Assessment of changes in participant perception of digestion, gas, mental health, and well-being associated with bloating through self-reported questionnaires taken at Baseline, first use, Week 2, and Week 4.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States