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

NCT06516744 | Completed

• 1 other identifier: 20402
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Health; Digestion

Keywords

Gastrointestinal Symptoms; Hormonal Bloating; Capsule Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Digestion and Mental Well-being

  Baseline, first use, Week 2, and Week 4

Study Arms (1)

Bye Bye Bloat Capsules

EXPERIMENTAL

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

Interventions

Bye Bye Bloat Capsules DIETARY_SUPPLEMENT

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.

Bye Bye Bloat Capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Love Wellness: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: February 8, 2024
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)