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Clinical Trials/NCT05520411
NCT05520411CompletedNot Applicable

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

HUM Nutrition, Inc.2 sites in 1 country25 target enrollmentStarted: July 1, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Perceived Changes in Bloating and Stomach Distention
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Perceived Changes in Bloating and Stomach Distention

Time Frame: 1 Week

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 Outcomes

  • Visible changes in stomach distension.(1 week)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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