NCT06570330

Adult HMO Supplementation and the Gut Microbiome

Assessing the Impact of Daily Supplementation of a Multi - Human Milk Oligosaccharide (HMO) Formulation on Adult Gut Microbiome Health

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Seeding Inc · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SuperHMO	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)
DIETARY_SUPPLEMENT	Non-GMO corn Maltodextrin, Rapid Absorption	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-11-01
• Completion: 2025-07-01
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: United States