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

N/ACompletedNCT05520411

HUM Nutrition, Inc.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Stomach Distended Bloating

Interventions

HUM Flatter MeDIETARY_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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

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)

Time frame: 1 Week

Secondary Outcomes

Visible changes in stomach distension.

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

Time frame: 1 week

Data from ClinicalTrials.gov

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