CompletedNot Applicable

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

United States25 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perceived Changes in Bloating and Stomach Distention

Timeframe: 1 Week

Trial details

NCT IDNCT05520411

SponsorHUM Nutrition, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-15

View on ClinicalTrials.gov More Stomach Distended trials