Healthy AdultsNCT06570330
Adult HMO Supplementation and the Gut Microbiome
A study testing SuperHMO and Non-GMO corn Maltodextrin, Rapid Absorption in people with Healthy Adults, run by Seeding Inc at 1 site in United States.
Trial summary
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- SuperHMO and Non-GMO corn Maltodextrin, Rapid Absorption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are between the ages of 18 and 40.
Who cannot join
- Participants cannot have taken prebiotic or probiotic supplements within 6 months of starting study. This includes prebiotic or probiotic powder or supplements with prebiotic or probiotic addition or multivitamin with probiotic addition. This does not include food with live probiotics in it like yogurt or kefir.
- Participants must not be pregnant or breastfeeding or trying to conceive within the study period.
- Participants must be residents of the United States with US postal service.
- Participants cannot have the following existing health conditions:
- Pre-existing gut conditions (IBD, Celiac's disease, Crohn's disease, SIBO)
- Immune or auto-immune conditions (Type 1 Diabetes, human immunodeficiency virus (HIV))
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- Participants cannot be lactose intolerant or have an allergy to dairy products.
- Participants are excluded if they have received results from an at home microbiome stool test in the past 6 months. This does not include clinical workup such as culture or pathogen testing.
- Participants must agree not to take another prebiotic or probiotic supplement or an at-home test over the study period.
- Participants must have no known major dietary changes upcoming.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Impact of Daily Supplementation of a Multi - Human Milk Oligosaccharide (HMO) Formulation on Adult Gut Microbiome Health
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. We will measure all participants\' gut microbiome using a gut health test before taking SuperHMO prebiotic or placebo and after 30 days of taking the supplement. We hypothesize that taking the SuperHMO prebiotic will improve gut health measurements such as the potential to produce short-chain fatty acids.
Read the detailed description
The investigators will enroll 24 healthy, adult volunteers into this double-blinded, randomized, placebo-controlled trial. Upon confirmation of eligibility and documentation of informed consent, the participants will be randomized to either SuperHMO (Layer Origin, 53% 2'FL, 15% LNT, 14%LNnT, 12% 6'SL, 6% 3'SL) prebiotic formulation at a dosage of (4.2 g/day) or placebo (maltodextrin, 4.2 g/day), self-administered at home and taken as a liquid solution in a beverage of choice by mouth once daily for 30 days. Participants will take a baseline survey at the beginning of the study and an exit survey at the end of the study assessing their current health, health history, diet, current and past supplement and medication use, and any GI symptoms or bowel irregularities. Participants will additionally take a baseline microbiome sample before beginning the daily regimen of taking the supplement or placebo for 30 days. At the end of the study, participants will take another microbiome sample and an exit survey to report changes to gut health, overall health, diet, and any adverse reactions. Gut microbiome outcomes will be analyzed both intra-individually, as a before and after comparison, and inter-individually to compare intervention and control groups.
- Conditions
- Healthy Adults
- Being tested
- SuperHMO, Non-GMO corn Maltodextrin, Rapid Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperHMODietary supplement
Super HMO Prebiotic Mix: five major types of human milk oligosaccharides including 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL)
Non-GMO corn Maltodextrin, Rapid AbsorptionDietary supplement
he composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - SuperHMO | Experimental | The investigation product is commercially available and is marketed as SuperHMO Prebiotic Mix with 5 HMOs. This product is a dietary supplement which contains five major types of human milk oligosaccharides includes 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL). SuperHMO is designed to boost the number and variety of beneficial bacteria in the gut by feeding them with five different kinds of human milk oligosaccharide prebiotics. This product does not contain any flavoring, colorants, preservatives or fillers. Each bottle contains 118 grams of the mix, 28 servings, with 4.2 grams per serving (2 scoops).
Study participants will be instructed to take 1 scoop (2.1 g) per day for the first five days and increase to 2 scoops (4.2g) per day for days 6-30, the formulation can be dissolved in their beverage of choice and taken at any time of the day, with or without food. Receives: Dietary Supplement: SuperHMO |
| Control | Placebo comparator | Control participants will receive a commercially available maltodextrin, NOW Sports Nutrition, Non-GMO corn Maltodextrin, Rapid Absorption. The composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. The use of maltodextrin as a comparator in prebiotic supplementation in human trials is well-documented. Receives: Dietary Supplement: Non-GMO corn Maltodextrin, Rapid Absorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative changes in the relative abundance of key bacterial taxa
The investigators will specifically measure the difference in Bifidobacterium spp., Akkermansia spp., Eubacterium rectale-Clostridium Coccoides group, and Faecalibacterium prausnitzii, at baseline and at 30 days.
Measured: 30 days
Detection of presence of specific HMO digestion genes
Comparing baseline and again after 30 days of taking the study product to assess potential changes in HMO metabolism by the gut microbiota.
Measured: 30 days
Assess Changes in the diversity metrics of the Gut Microbiome
Measuring the change in alpha diversity (e.g., Shannon index) and beta diversity metrics (e.g., Bray-Curtis dissimilarity) to evaluate overall microbial diversity and community structure shifts between baseline and at 30 days.
Measured: 30 days
Evaluate Changes in Metabolic Markers
Assess the change in SCFA (namely acetate, propionate, and butyrate) production potential from baseline to 30 days.
Measured: 30 days
Evaluate Changes in Inflammation Markers
Evaluation of the change in gut inflammatory markers (e.g., hexa-LPS Index, mucus degradation species, hydrogen sulfide levels) between at baseline and at 30 days to investigate potential anti-inflammatory effects of HMO supplementation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Aug 2024
- Primary completion6 Dec 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seeding Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570330
- Sponsor's protocol ID
- LO_12186.01
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 24 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Daily Supplementation of a Multi - Human Milk Oligosaccharide (HMO) Formulation on Adult Gut Microbiome Health
- ClinicalTrials.gov ID
- NCT06570330
- Acronym / sponsor ID
- LO_12186.01
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seeding IncIndustry (pharma, biotech, devices)
- Collaborators
- Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Aug 2024 (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.
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. We will measure all participants\' gut microbiome using a gut health test before taking SuperHMO prebiotic or placebo and after 30 days of taking the supplement. We hypothesize that taking the SuperHMO prebiotic will improve gut health measurements such as the potential to produce short-chain fatty acids.
Detailed description
The investigators will enroll 24 healthy, adult volunteers into this double-blinded, randomized, placebo-controlled trial. Upon confirmation of eligibility and documentation of informed consent, the participants will be randomized to either SuperHMO (Layer Origin, 53% 2'FL, 15% LNT, 14%LNnT, 12% 6'SL, 6% 3'SL) prebiotic formulation at a dosage of (4.2 g/day) or placebo (maltodextrin, 4.2 g/day), self-administered at home and taken as a liquid solution in a beverage of choice by mouth once daily for 30 days. Participants will take a baseline survey at the beginning of the study and an exit survey at the end of the study assessing their current health, health history, diet, current and past supplement and medication use, and any GI symptoms or bowel irregularities. Participants will additionally take a baseline microbiome sample before beginning the daily regimen of taking the supplement or placebo for 30 days. At the end of the study, participants will take another microbiome sample and an exit survey to report changes to gut health, overall health, diet, and any adverse reactions. Gut microbiome outcomes will be analyzed both intra-individually, as a before and after comparison, and inter-individually to compare intervention and control groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - SuperHMO | Experimental | Dietary Supplement: SuperHMOThe investigation product is commercially available and is marketed as SuperHMO Prebiotic Mix with 5 HMOs. This product is a dietary supplement which contains five major types of human milk oligosaccharides includes 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL). SuperHMO is designed to boost the number and variety of beneficial bacteria in the gut by feeding them with five different kinds of human milk oligosaccharide prebiotics. This product does not contain any flavoring, colorants, preservatives or fillers. Each bottle contains 118 grams of the mix, 28 servings, with 4.2 grams per serving (2 scoops). Study participants will be instructed to take 1 scoop (2.1 g) per day for the first five days and increase to 2 scoops (4.2g) per day for days 6-30, the formulation can be dissolved in their beverage of choice and taken at any time of the day, with or without food. |
| Control | Placebo comparator | Dietary Supplement: Non-GMO corn Maltodextrin, Rapid AbsorptionControl participants will receive a commercially available maltodextrin, NOW Sports Nutrition, Non-GMO corn Maltodextrin, Rapid Absorption. The composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. The use of maltodextrin as a comparator in prebiotic supplementation in human trials is well-documented. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants are between the ages of 18 and 40.
Key exclusion criteria (10 listed)
- Participants cannot have taken prebiotic or probiotic supplements within 6 months of starting study. This includes prebiotic or probiotic powder or supplements with prebiotic or probiotic addition or multivitamin with probiotic addition. This does not include food with live probiotics in it like yogurt or kefir.
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 |
|---|---|---|
| SuperHMOSuper HMO Prebiotic Mix: five major types of human milk oligosaccharides including 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL) | Dietary supplement | Intervention - SuperHMO |
| Non-GMO corn Maltodextrin, Rapid Absorptionhe composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. | Dietary supplement | Control |
Primary outcome
Quantitative changes in the relative abundance of key bacterial taxa
Time frame: 30 days
The investigators will specifically measure the difference in Bifidobacterium spp., Akkermansia spp., Eubacterium rectale-Clostridium Coccoides group, and Faecalibacterium prausnitzii, at baseline and at 30 days.
Detection of presence of specific HMO digestion genes
Time frame: 30 days
Comparing baseline and again after 30 days of taking the study product to assess potential changes in HMO metabolism by the gut microbiota.
Assess Changes in the diversity metrics of the Gut Microbiome
Time frame: 30 days
Measuring the change in alpha diversity (e.g., Shannon index) and beta diversity metrics (e.g., Bray-Curtis dissimilarity) to evaluate overall microbial diversity and community structure shifts between baseline and at 30 days.
Evaluate Changes in Metabolic Markers
Time frame: 30 days
Assess the change in SCFA (namely acetate, propionate, and butyrate) production potential from baseline to 30 days.
Evaluate Changes in Inflammation Markers
Time frame: 30 days
Evaluation of the change in gut inflammatory markers (e.g., hexa-LPS Index, mucus degradation species, hydrogen sulfide levels) between at baseline and at 30 days to investigate potential anti-inflammatory effects of HMO supplementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperHMO and Non-GMO corn Maltodextrin, Rapid Absorption in people with Healthy Adults, run by Seeding Inc 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative changes in the relative abundance of key bacterial taxa (time frame: 30 days). The study lists 5 primary outcomes in all. 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 24 Apr 2026.