Digestive Enzymes for Abdominal Bloating

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: HUM Nutrition, Inc.

Must not be taking: Gut health meds, Fluid balance meds, Antibiotics, Iron supplements

Disqualifiers: Pregnancy, IBS, GERD, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a product called Flatter Me can reduce bloating and stomach swelling after eating. Researchers aim to determine if participants feel less bloated and if their waist size changes after taking Flatter Me compared to a placebo. Flatter Me contains natural enzymes and herbs that support digestion. Individuals who frequently experience bloating or stomach swelling after meals may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to explore a natural solution for digestive discomfort.

Will I have to stop taking my current medications?

If you are currently taking any prescribed medication for gut health or fluid balance, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that HUM Flatter Me is likely to be safe for humans?

Research has shown that HUM Flatter Me, a digestive enzyme supplement, is generally safe for most people. However, some users have experienced mild stomach issues, and allergic reactions may occur. It might also interact with other medications. There is not enough information about its long-term safety yet. While many people tolerate short-term use well, anyone with specific health concerns or who is pregnant or breastfeeding should consult a healthcare provider before using this supplement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike most treatments for bloating and stomach distension, which typically involve dietary changes or medications that reduce gas production, HUM Flatter Me offers a unique approach by using a blend of digestive enzymes. These enzymes help to break down food more efficiently, potentially reducing bloating by addressing the root cause of indigestion. Researchers are excited about HUM Flatter Me because it targets multiple components of digestion, which could lead to faster and more comprehensive relief for individuals suffering from these uncomfortable symptoms.

What evidence suggests that HUM Flatter Me might be an effective treatment for digestive health?

Research has shown that HUM Flatter Me, the treatment under study in this trial, can reduce bloating by up to 80% after just one use. In previous studies, participants who took Flatter Me felt less bloated compared to those who took a placebo (a pill with no active ingredients). The supplement contains natural ingredients that help break down proteins, fats, and carbohydrates, relieving feelings of fullness and discomfort. These findings suggest that Flatter Me may benefit those who experience bloating or digestion issues after eating. ^{4 6 7 8 9}

Who Is on the Research Team?

Christopher Hill, PhD

Principal Investigator

Citruslabs

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take either the Flatter Me product or a placebo and eat a test meal to assess changes in bloating and stomach distension

1 week

2 visits (in-person, 1 week gap between visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HUM Flatter Me

How Is the Trial Designed?

Group I: HUM Flatter Me Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

HUM Nutrition, Inc.

Lead Sponsor

Trials

2

Recruited

140+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Published Research Related to This Trial

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

Citations

1. humnutrition.com humnutrition.com/blog/flatter-me-clinical-trial-results/?srsltid=AfmBOooWJFM4ym4XGIaIjkpEV5Lgbqgd2_xr9utQBesXvHNaastKISYo

HUM Nutrition's Flatter Me Is Clinically Shown to Reduce ... HUM's Flatter Me digestive enzyme supplement has been clinically shown to reduce bloating by up to 80% after just one use and reduce ...

2. withpower.com withpower.com/trial/phase-gastric-dilatation-6-2022-92f1c

Examining the Effectiveness of Digestive Enzymes at ... This trial tests Flatter Me, a supplement with digestive enzymes and herbs, to see if it helps people who feel bloated or have indigestion after eating.

3. ctv.veeva.com ctv.veeva.com/study/examining-the-effectiveness-of-digestive-enzymes-at-reducing-bloating-and-stomach-distension

Examining the Effectiveness of Digestive Enzymes at ... Flatter Me is a product that includes digestive enzymes in a way to support digestion of macronutrients and their constituents and provides ...

4. healthline.com healthline.com/nutrition/hum-nutrition-review

HUM Nutrition Review: A Dietitian's Take According to a study conducted by HUM, people taking the supplement had 20% lower stress scores after taking Big Chill for 2 weeks. However, HUM funded the ...

5. citruslabs.com citruslabs.com/testedproducts/hum-flatter-me

HUM - Bloating | citruslabs.com Overall, participants experienced a significant reduction in bloating when using Flatter Me compared to the placebo condition in this trial. On average, ...

6. amazon.com amazon.com/HUM-Flatter-Me-Digestive-Bloating/dp/B015OVVI4Q

HUM Flatter Me Digestive Enzymes for Women & Men ... This item is non-returnable due to potential safety risk as an ingestible product, but if the item arrives damaged or defective, you may request a refund or ...

7. staging.evenant.com staging.evenant.com/Resources/8ldDFL/270001/hum__flatter-me_side_effects.pdf

Hum Flatter Me Side Effects Cons: Possible mild digestive issues; risk of allergic reactions; potential interactions with medications; insufficient long-term safety data. Consumer ...

8. humnutrition.com humnutrition.com/product/23/flatter-me?srsltid=AfmBOor9rPwGlmoZ6q5ro-KulXVQdQbkAumQ6YuC-vNzfKTnbqAN3vH8

Flatter Me | Best Bloat Relief Supplement with Digestive ... Flatter Me is our most extensively studied formula, validated by a double-blind, placebo-controlled gold standard clinical trial to ensure results you can see ...

9. staging.evenant.com staging.evenant.com/Resources/8ldDFL/270001/hum_flatter-me_side__effects.pdf

Hum Flatter Me Side Effects The safety of Hum Flatter Me during pregnancy or breastfeeding has not been established. Pregnant or breastfeeding women should consult their.