Bloating, Stomach Distended
Conditions
Keywords
digestion, bloating
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.
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
Sponsors
Citruslabs
HUM Nutrition, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Changes in Bloating and Stomach Distention | 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
| Measure | Time frame | Description |
|---|---|---|
| Visible changes in stomach distension. | 1 week | Participants will have their waist measured at multiple time points while in the lab |
Countries
United States
Outcome results
None listed