Adult HMO Supplementation and the Gut Microbiome

NCT06570330 | Completed

• 1 other identifier: LO_12186.01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  30 days

• Evaluate Changes in Metabolic Markers

  Assess the change in SCFA (namely acetate, propionate, and butyrate) production potential from baseline to 30 days.

  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.

  30 days

Study Arms (2)

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.

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.

Dietary Supplement: Non-GMO corn Maltodextrin, Rapid Absorption

Interventions

SuperHMO DIETARY_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)

Intervention - SuperHMO

Non-GMO corn Maltodextrin, Rapid Absorption DIETARY_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.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are between the ages of 18 and 40.

You may not qualify if:

• 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))
• 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.

Sponsors & Collaborators

• Mellitas Health Foods, LLC (DBA Layer Origin Nutrition): collaborator
• Seeding Inc: lead

Study Sites (1)

Seeding Inc

Rockville, Maryland, 20850, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 26, 2024
• Study Start: August 22, 2024
• Primary Completion: December 6, 2024
• Study Completion: July 30, 2025
• Last Updated: April 24, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)