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

HUM Nutrition

Status: Completed

Conditions: Bloating; Stomach Distended

Treatments: Dietary Supplement: HUM Flatter Me

Study type: Interventional

Funder types: Industry

Identifiers

NCT05520411

20240

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

HUM Flatter Me

Experimental group

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

Treatment:

Dietary Supplement: HUM Flatter Me