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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stomach Distended, Bloating

Intervention / Treatment
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* Dietary Supplement: HUM Flatter Me


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HUM Flatter Me<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visible changes in stomach distension. | Participants will have their waist measured at multiple time points while in the lab | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digestion, bloating