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

NCT05520411 | Completed

• 1 other identifier: 20240
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Distended; Bloating

Keywords

digestion; bloating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visible changes in stomach distension.

  1 week

Study Arms (1)

HUM Flatter Me

EXPERIMENTAL

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

Dietary Supplement: HUM Flatter Me

Interventions

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

HUM Flatter Me

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HUM Nutrition, Inc.: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Gastric Dilatation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Christopher Hill, PhD

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: July 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (1)