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

Bloating Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520411
• Other study ID #: 20240
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: March 2023
• Source: HUM Nutrition, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bloating

Intervention

Dietary Supplement:
• HUM Flatter Me
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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
HUM Nutrition, Inc.	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Changes in Bloating and Stomach Distention	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)	1 Week
Secondary	Visible changes in stomach distension.	Participants will have their waist measured at multiple time points while in the lab	1 week