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OpenTrials
Completed

NCT Number: NCT05520411

Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension

Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides herbs traditionally used for digestive health support. This trial aims to test Flatter Me against a placebo pill to examine differences in both subjective outcomes (feelings of bloating and indigestion) and changes in waist circumference (abdominal distension) after eating a test meal.

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Key information

Conditions

Stomach Distended Bloating Digestive System Diseases Gastric Dilatation Gastrointestinal Diseases Stomach Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

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

  • Self Report bloating or stomach distension at least once per day after eating

Exclusion criteria

  • Females who are pregnant or breastfeeding
  • Currently taking any prescribed medication meant to treat gut health
  • Currently taking any medication for fluid balance (i.e., Aldactone)
  • Currently suffers from any pre-existing condition that would prevent them from adhering to the protocol.
  • Currently suffers from any pre-existing condition that would prevent them from consuming cheese pizza.
  • Use of an antibiotic in the previous 3 months.
  • Taking an iron supplement with > 65mg of iron in the last week.
  • Diagnosed with any of IBS, chronic constipation, GERD, Crohn's Disease, ulcerative colitis, celiac disease, liver disease, kidney disease, heart failure.
  • Lactose Allergy or Intolerance
  • Any food allergies
  • Current smoker
  • Wears dentures

Treatment and study plan

HUM Flatter Me

Dietary Supplement

Proprietary Enzyme Blend: Protease 3.0 Protease 4.5 Protease 6.0 Neutral Bacterial Protease Peptidase Bromelain Papain Lipase Amylase Glucoamylase Alpha-galactosidase Invertase Diastase Hemicellulase + Cellulase Beta-Glucanase Phytase Lactase Ginger Root Fennel Seed Peppermint Leaf

Primary outcomes

  1. Perceived Changes in Bloating and Stomach Distention

    Time frame: 1 Week

    Questionnaires will be administered to participants at multiple time points before and after eating a test meal. Symptom severity is rated on a scale of 0 (None) to 4 (Extremely Severe)

Secondary outcomes

  1. Visible changes in stomach distension.

    Time frame: 1 week

    Participants will have their waist measured at multiple time points while in the lab

Sponsors and collaborators

Lead sponsor

HUM Nutrition, Inc.

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Mar 16, 2023

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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