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

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.

Study Overview

• Status: Completed
• Conditions: Digestion; Digestive Health
• Intervention / Treatment: Dietary supplement: Bye Bye Bloat Capsules

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Dietary supplement: Bye Bye Bloat Capsules; Bye Bye Bloat Capsules contain the following ingredients: Organic Fenugreek Seed Powder, Organic Dandelion Root Powder, Organic Fennel Seed Powder, Organic Ginger Root Powder, Organic Parsley Leaf Powder, Amylase Complex, Protease Complex, Pepsin Complex, Lipase Complex, Bromelain Complex, Papain Complex. Other ingredients include Hypromellose Capsule, Maltodextrin, Microcrystalline Cellulose, and Magnesium Stearate. Participants will take 2 capsules immediately after eating at least 3 times a week and during times of hormonal bloating for 4 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Digestion and Mental Well-being	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.	Baseline, first use, Week 2, and Week 4

Collaborators and Investigators

• Sponsor: Love Wellness
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): April 20, 2024
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Gastrointestinal Symptoms; Hormonal Bloating; Capsule Supplement
• Other Study ID Numbers: 20402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No