CClinicalTrials.gg
CompletedNCT05520411Updated Mar 16, 2023

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

An interventional study of HUM Flatter Me in Stomach Distended and Bloating, sponsored by HUM Nutrition, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by HUM Nutrition, Inc. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stomach Distended
  • Bloating

Keywords

  • digestion
  • bloating
03

In context

Lead sponsor

HUM Nutrition, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    HUM Flatter Me

    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

  • Dietary supplementHUM 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

06

What researchers measure

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)

    Time frame: 1 Week

Secondary outcomes

  1. Visible changes in stomach distension.

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

    Time frame: 1 week

07

Study locations

1 site
  • Citruslabs
    Santa Monica, California 90404, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05520411
Lead sponsor
HUM Nutrition, Inc.
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Jul 1, 2022
Primary completion
Jan 15, 2023
Completion
Jan 15, 2023
Last update
Mar 16, 2023

Study contacts

Christopher Hill, PhD
principal investigator · Citruslabs

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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