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

Not Applicable

Completed

• Conditions: Bloating; Stomach Distended
• Interventions: Dietary Supplement: HUM Flatter Me

• Registration Number: NCT05520411
• Lead Sponsor: HUM Nutrition, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HUM Flatter Me	HUM Flatter Me	Come to Citruslabs Office twice (1 Week Gap Between Visits) Visit 1: Take Placebo or Test Product; Eat Test Meal; Outcome Measures Visit 2: Take Placebo or Test Product; Eat Test Meal; Outcome Measures

Primary Outcome Measures

Name	Time	Method
Perceived Changes in Bloating and Stomach Distention	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 Outcome Measures

Name	Time	Method
Visible changes in stomach distension.	1 week	Participants will have their waist measured at multiple time points while in the lab

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States