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OpenTrials
Completed

NCT Number: NCT06516744

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.

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Key information

Conditions

Digestive Health Digestion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reduction in Bloating

    Time frame: 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 outcomes

  1. Improvement in Digestion and Mental Well-being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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