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

Primary Purpose

Stomach Distended, Bloating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HUM Flatter Me
Sponsored by
HUM Nutrition, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stomach Distended focused on measuring digestion, bloating

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HUM Flatter Me

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Visible changes in stomach distension.
Participants will have their waist measured at multiple time points while in the lab

Full Information

First Posted
August 26, 2022
Last Updated
March 14, 2023
Sponsor
HUM Nutrition, Inc.
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05520411
Brief Title
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Official Title
Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HUM Nutrition, Inc.
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Distended, Bloating
Keywords
digestion, bloating

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HUM Flatter Me
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
HUM Flatter Me
Intervention Description
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
Primary Outcome Measure Information:
Title
Perceived Changes in Bloating and Stomach Distention
Description
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 Outcome Measure Information:
Title
Visible changes in stomach distension.
Description
Participants will have their waist measured at multiple time points while in the lab
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, PhD
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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