Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570330
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Adult HMO Supplementation and the Gut Microbiome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Impact of Daily Supplementation of a Multi - Human Milk Oligosaccharide HMO Formulation on Adult Gut Microbiome Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to assess the impact of Layer Origins 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 participants39 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 2FL 15 LNT 14LNnT 12 6SL 6 3SL prebiotic formulation at a dosage of 42 gday or placebo maltodextrin 42 gday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None