Healthy ParticipantsNCT07525180
Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort
A study testing LOAM and Inulin in people with Healthy Participants, run by Ventoscity LLC at 1 site in United States.
Trial summary
This study compares three dietary fiber supplements - LOAM prebiotic fiber, inulin, and a cellulose placebo - to evaluate their effects on intestinal gas production and gastrointestinal comfort in healthy adults who currently eat a low-fiber diet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy Participants
- What is being tested?
- LOAM and Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults aged 18 to 65 years
- Body mass index 18.5 to 30 kg/m2
- Habitual daily fiber intake of fewer than 10 grams per day, as self-reported at screening
- No current use of fiber supplements, prebiotic supplements, or probiotic supplements
- No use of fiber supplements, prebiotics, probiotics, or antibiotics within the past 4 months
- Willing and able to consume one daily fiber supplement (mixed with water) for the duration of the study
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- Willing and able to wear the Ventos intestinal gas monitoring device for approximately 22 hours on designated monitoring days (Tuesdays and Saturdays) for the full 5-week study period
- Willing and able to complete daily and weekly digital questionnaires and symptom diaries using the Alethios platform
- Access to a smartphone or computer with internet access
- Able to read and understand English
- Non-user (never used, or former user defined as cessation 12 or more months) of tobacco or nicotine products with no plans to begin use during the study period
- Willing to maintain habitual diet, physical activity, and body weight throughout the trial
- Willing to refrain from exclusionary medications, supplements, and products throughout the study
- Willing to provide informed consent electronically
- Not currently enrolled in any other clinical trial, supplement study, or consumer health research study
Who cannot join
- Diagnosis of any gastrointestinal condition, including but not limited to IBS, IBD (Crohn's Disease or Ulcerative Colitis), celiac disease, diverticulitis, gastroparesis, clinically significant lactose or gluten intolerance or other food or ingredient allergies, or any chronic or acute GI condition requiring medical management (e.g., GERD)
- Perception that they have more than 40 flatus per day
- Currently undergoing chemotherapy or any other treatment that affects the digestive system
- Known allergy or sensitivity to any ingredient in the study supplement
- Unwilling to discontinue any current fiber supplement use at least 14 days prior to study initiation
- Habitual dietary fiber intake of 10 or more grams per day
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- 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
- Participation in another research study within 30 days prior to screening that could confound study outcomes
- Recent history (within 12 months of screening) of alcohol or substance abuse
- Habitual use (daily) of marijuana and hemp products including CBD products within 30 days of screening
- Currently or planning to be on a weight loss regimen during the study
- Use of weight loss medications, incretin mimetics, and/or GLP-1 agonists in the 3 months prior to screening
- Chronic use (daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDs) within 1 month of screening
- Expected to receive a COVID-19 vaccine during the study period
- Antibiotic use within 3 months of screening and throughout the study period
- Any medical condition that would make participation unsafe or interfere with data quality
- Currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alethios
San Francisco, California, 94109
Zeenia Framroze, (650) 206-8006
About this study
This study compares three dietary fiber supplements - LOAM prebiotic fiber, inulin, and a cellulose placebo - to evaluate their effects on intestinal gas production and gastrointestinal comfort in healthy adults who currently eat a low-fiber diet.
Participants will be randomly assigned to one of the three supplements and asked to take one daily serving mixed with water for four weeks. Intestinal gas production will be measured using Ventos, a wearable device that continuously monitors intestinal gas when worn near the body. Participants wear the device for approximately 22 hours on two designated days per week throughout the 5-week study. Gastrointestinal symptoms including bloating, abdominal discomfort, and stool consistency will be tracked daily using a symptom diary and standardized questionnaires.
Read more
The study is conducted entirely remotely. Participants receive their supplement and the Ventos device by mail and complete all study activities from home using a smartphone or computer. The study runs for five weeks, including one baseline week before supplementation begins.
The goal is to determine whether LOAM prebiotic fiber causes less intestinal gas and better gastrointestinal tolerability during the initial weeks of supplementation compared to inulin, while also validating the Ventos device as a research measurement tool in a controlled supplement study.
- Conditions
- Healthy Participants
- Being tested
- LOAM, Inulin, Cellulose Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOAMDietary supplement
12 grams of LOAM daily
InulinDietary supplement
12 Grams Inulin daily
Cellulose PlaceboDietary supplement
12 grams of cellulose placebo daily
| Study group | Role | What they receive |
|---|---|---|
| LOAM | Experimental | 12 grams LOAM prebiotic daily Receives: Dietary Supplement: LOAM |
| Inulin | Active comparator | 12 grams inulin daily Receives: Dietary Supplement: Inulin |
| Cellulose Placebo | Placebo comparator | 12 grams cellulose daily Receives: Dietary Supplement: Cellulose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin
Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. The primary analysis compares the change from Week 1 (baseline, no supplementation) to Week 2 (first week of supplementation) between the LOAM and inulin groups using ANCOVA, with baseline average daily flatus as a covariate.
Measured: Baseline (Week 1) to Week 2 (first week of supplementation)
Secondary outcomes (11)
Change in Average Daily Flatus from Baseline (Week 1) to Weeks 3, 4, and 5
Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. Changes from baseline (Week 1) to Weeks 3, 4, and 5 will be summarized using descriptive statistics and compared between treatment groups using ANCOVA models, with baseline values as covariates.
Measured: Baseline (Week 1) to Weeks 3, 4, and 5
Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose
Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. Pairwise comparisons across study arms (LOAM, inulin, cellulose) will be conducted.
Measured: Weeks 1 through 5
Microbiome Activity Index
The microbiome activity index is defined as the number of Ventos-derived data points exceeding a standardized threshold, evaluated as change from baseline (Week 1) to Weeks 2, 3, 4, and 5, and as comparisons across LOAM, inulin, and cellulose groups. The microbiome activity index will be interpreted as a proxy measure of intestinal gas volume.
Measured: Baseline (Week 1) to Weeks 2, 3, 4, and 5
Daily GI Symptom Diary - Bristol Stool Scale
Stool consistency assessed daily using the Bristol Stool Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models.
Measured: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Abdominal Discomfort
Abdominal discomfort assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models.
Measured: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Bloating
Bloating assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models.
Measured: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Intestinal Gas Severity
Intestinal gas severity assessed daily on a 0-10 Numerical Rating Scale, administered each evening through the Alethios platform. Daily diary outcomes may be summarized as weekly averages or analyzed using longitudinal models.
Measured: Daily over 5 weeks (Days 1-35)
PROMIS-GI Gas and Bloating 13A Score
The PROMIS-GI Gas and Bloating 13A instrument is a validated, patient-reported outcome measure developed by the National Institutes of Health PROMIS initiative. Scores will be evaluated weekly and as change from baseline to end of study. Administered at baseline (Week 1), Week 2, Week 3, Week 4, and Week 5.
Measured: Baseline (Week 1) to Week 5
GAD-7 Score
General psychological well-being assessed using the GAD-7 anxiety screening instrument, evaluated as change from baseline to Week 5.
Measured: Baseline (Week 1) to Week 5
Adaptation to Supplementation
Adaptation to supplementation is defined as the change in average daily flatus, as measured by Ventos, from Week 2 to Week 5. LOAM is expected to demonstrate a greater reduction over time compared to inulin.
Measured: Week 2 to Week 5
Supplement Compliance
Supplement compliance is defined as the proportion of doses taken per protocol, assessed via daily GI symptom diary supplement intake responses (full dose, partial dose, or missed dose).
Measured: Weeks 2 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventoscity LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GutWise Inc. (dba LOAM Science)
- Responsible party
- Principal investigator, Andrew Brantley Hall, Ventoscity LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525180
- Sponsor's protocol ID
- LOA002
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Prebiotic Fiber Supplements for Gut Health and Digestive Comfort
- ClinicalTrials.gov ID
- NCT07525180
- Acronym / sponsor ID
- LOA002
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Ventoscity LLCIndustry (pharma, biotech, devices)
- Collaborators
- GutWise Inc. (dba LOAM Science)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares three dietary fiber supplements - LOAM prebiotic fiber, inulin, and a cellulose placebo - to evaluate their effects on intestinal gas production and gastrointestinal comfort in healthy adults who currently eat a low-fiber diet.
Participants will be randomly assigned to one of the three supplements and asked to take one daily serving mixed with water for four weeks. Intestinal gas production will be measured using Ventos, a wearable device that continuously monitors intestinal gas when worn near the body. Participants wear the device for approximately 22 hours on two designated days per week throughout the 5-week study. Gastrointestinal symptoms including bloating, abdominal discomfort, and stool consistency will be tracked daily using a symptom diary and standardized questionnaires.
The study is conducted entirely remotely. Participants receive their supplement and the Ventos device by mail and complete all study activities from home using a smartphone or computer. The study runs for five weeks, including one baseline week before supplementation begins.
The goal is to determine whether LOAM prebiotic fiber causes less intestinal gas and better gastrointestinal tolerability during the initial weeks of supplementation compared to inulin, while also validating the Ventos device as a research measurement tool in a controlled supplement study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LOAM | Experimental | Dietary Supplement: LOAM12 grams LOAM prebiotic daily |
| Inulin | Active comparator | Dietary Supplement: Inulin12 grams inulin daily |
| Cellulose Placebo | Placebo comparator | Dietary Supplement: Cellulose Placebo12 grams cellulose daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female adults aged 18 to 65 years
- Body mass index 18.5 to 30 kg/m2
- Habitual daily fiber intake of fewer than 10 grams per day, as self-reported at screening
- No current use of fiber supplements, prebiotic supplements, or probiotic supplements
- No use of fiber supplements, prebiotics, probiotics, or antibiotics within the past 4 months
Key exclusion criteria (17 listed)
- Diagnosis of any gastrointestinal condition, including but not limited to IBS, IBD (Crohn's Disease or Ulcerative Colitis), celiac disease, diverticulitis, gastroparesis, clinically significant lactose or gluten intolerance or other food or ingredient allergies, or any chronic or acute GI condition requiring medical management (e.g., GERD)
- Perception that they have more than 40 flatus per day
- Currently undergoing chemotherapy or any other treatment that affects the digestive system
- Known allergy or sensitivity to any ingredient in the study supplement
- Unwilling to discontinue any current fiber supplement use at least 14 days prior to study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOAM12 grams of LOAM daily | Dietary supplement | LOAM |
| Inulin12 Grams Inulin daily | Dietary supplement | Inulin |
| Cellulose Placebo12 grams of cellulose placebo daily | Dietary supplement | Cellulose Placebo |
Primary outcome
Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin
Time frame: Baseline (Week 1) to Week 2 (first week of supplementation)
Average daily flatus as measured by the Ventos wearable intestinal gas monitoring device, defined as the mean of Ventos-measured flatus counts obtained on Tuesday and Saturday of each week. The primary analysis compares the change from Week 1 (baseline, no supplementation) to Week 2 (first week of supplementation) between the LOAM and inulin groups using ANCOVA, with baseline average daily flatus as a covariate.
11 secondary outcomes
Change in Average Daily Flatus from Baseline (Week 1) to Weeks 3, 4, and 5
Time frame: Baseline (Week 1) to Weeks 3, 4, and 5
Comparisons of Average Daily Flatus Between LOAM and Cellulose, and Between Inulin and Cellulose
Time frame: Weeks 1 through 5
Microbiome Activity Index
Time frame: Baseline (Week 1) to Weeks 2, 3, 4, and 5
Daily GI Symptom Diary - Bristol Stool Scale
Time frame: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Abdominal Discomfort
Time frame: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Bloating
Time frame: Daily over 5 weeks (Days 1-35)
Daily GI Symptom Diary - Intestinal Gas Severity
Time frame: Daily over 5 weeks (Days 1-35)
PROMIS-GI Gas and Bloating 13A Score
Time frame: Baseline (Week 1) to Week 5
GAD-7 Score
Time frame: Baseline (Week 1) to Week 5
Adaptation to Supplementation
Time frame: Week 2 to Week 5
Supplement Compliance
Time frame: Weeks 2 through 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOAM and Inulin in people with Healthy Participants, run by Ventoscity LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Daily Flatus from Baseline (Week 1) to Week 2, Comparing LOAM Prebiotic Fiber to Inulin (time frame: Baseline (Week 1) to Week 2 (first week of supplementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.