What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three dietary fiber supplements to assess their impact on gut health, focusing on gas production and stomach comfort. Participants will take either LOAM prebiotic fiber, inulin, or a placebo (a look-alike supplement with no active ingredient) for four weeks. The study evaluates whether LOAM is gentler on the stomach and produces less gas than inulin, while also testing a new device that monitors intestinal gas. Individuals who consume less than 10 grams of fiber daily and are willing to wear a gas-monitoring device may be suitable candidates. All activities occur remotely, allowing participants to join from home. As an unphased trial, this study provides a unique opportunity to contribute to innovative research from the comfort of home.

Do I need to stop taking my current medications for the trial?

The trial requires participants to refrain from using certain medications, supplements, and products throughout the study. If you are currently using fiber supplements, prebiotics, probiotics, or antibiotics, you must stop at least 14 days before the study begins.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that LOAM prebiotic fiber was well-tolerated, meaning most people did not experience significant negative effects, even under stress. This suggests that LOAM is generally safe for most individuals.

Research shows that inulin is safe for most healthy adults when taken in amounts less than 40 grams per day. However, some people have reported mild side effects like bloating and gas, which usually resolve on their own.

Overall, studies have shown that both LOAM and inulin are safe, with only mild and manageable side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about these prebiotic fiber supplements because they offer a new way to support gut health. Unlike standard probiotics that introduce live bacteria into the gut, LOAM and inulin work by nourishing the beneficial bacteria already present, promoting a healthier gut environment. LOAM is especially intriguing because it utilizes a unique blend of fibers that could potentially offer enhanced benefits over traditional options like inulin. By targeting the gut microbiome differently, these supplements hold promise for improving digestion and overall gut function more effectively.

What evidence suggests that this trial's treatments could be effective for gut health?

This trial will compare the effects of different prebiotic fiber supplements on gut health. Research has shown that LOAM prebiotic fiber, one of the treatments in this trial, can improve gut health by altering the bacterial composition. Some studies suggest that LOAM increases beneficial bacteria like Bifidobacterium, which can enhance gut health. LOAM also helps protect the gut lining and is generally well-tolerated.

Inulin, another treatment option in this trial, has been found in research to aid bowel movements by increasing stool frequency and reducing constipation when taken at 12 grams a day. It also appears to alleviate gut-related issues like stomach discomfort. However, some individuals might experience bloating and gas with inulin use.23678

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who eat less than 10 grams of fiber daily, are not currently using fiber or probiotic supplements, have no digestive diseases or major food allergies, and can use a smartphone or computer. Participants must be willing to take a daily supplement and wear a gas-monitoring device at home.

Inclusion Criteria

Able to read and understand English
Not currently enrolled in any other clinical trial, supplement study, or consumer health research study
I do not use tobacco or nicotine and have not used them for at least 12 months.
See 12 more

Exclusion Criteria

Consumption of supplemental inulin/chicory root or inulin/chicory root-fortified foods and beverages equivalent to more than 10 g inulin per day within 1 month of screening
Habitual use (daily) of marijuana and hemp products including CBD products within 30 days of screening
Perception that they have more than 40 flatus per day
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline

Participants establish baseline measurements without supplementation

1 week
Remote monitoring

Treatment

Participants take one daily serving of assigned supplement for four weeks

4 weeks
Remote monitoring with Ventos device

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
Remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Cellulose Placebo
  • Inulin
  • LOAM

Trial Overview

The study compares three daily fiber supplements—LOAM prebiotic fiber, inulin, and cellulose placebo—to see how they affect intestinal gas and digestive comfort over four weeks. Participants are randomly assigned to one group and complete all activities remotely.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: LOAMExperimental Treatment1 Intervention
Group II: InulinActive Control1 Intervention
Group III: Cellulose PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ventoscity LLC

Lead Sponsor

GutWise Inc. (dba LOAM Science)

Collaborator

Citations

Inulin-induced improvements on bowel habit and gut ... - PMC

Daily intake of 12 g inulin improves functional constipation by increasing stool frequency, positively affecting abdominal symptoms and well- ...

Inulin as a multifunctional prebiotic: from gut modulation to ...

One study reported that inulin supplementation ameliorated gut dysbiosis, elevated SCFA concentrations, and upregulated angiopoietin-like protein 4 (ANGPTL4) ...

A randomized trial of inulin for bowel symptoms ...

As a result, total IBS-QoL score increased in the prebiotic group (61.0 ± 19.4 to 77.4 ± 15.1; p < 0.006), whereas total IBS-SSS score decreased ...

Differential effects of inulin and fructooligosaccharides on gut ...

Notably, in this study, although FOS did not improve glycemic metabolism, it reduced HCY level, indicating a potential cardiovascular benefit.

Link between gut microbiota and health outcomes in inulin ...

The prebiotic induced greater weight loss and additionally decreased diastolic blood pressure, AST and insulinemia. Metformin treatment compromised most of the ...

Immunomodulatory effects of inulin and its intestinal metabolites

Inulin consumption under 40 g per day in healthy adults is safe. However, inulin can cause serious side effects in patients with inflammatory bowel disease (IBD) ...

Inulin (a prebiotic fiber): Health benefits and risks

Researchers have studied the different forms of inulin extensively, and it appears to be safe for most people in small doses. However, people who are intolerant ...

The Prebiotic Potential of Inulin-Type Fructans

Beneficial health effects reported following ITF intake include improved intestinal barrier function, improved laxation, increased insulin sensitivity, ...