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Effect of a Nutritional Supplement on Gut Microbiota in Adults

NCT06611215 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-24

No results posted yet for this study

Summary

According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.

Conditions

  • Changes in Gut Microbiota with Prebiotic Supplementation
  • Quality of Life

Interventions

DIETARY_SUPPLEMENT

Treatment

Prebiotic 1 - Stick pack of combination 1 of two polysaccharides mixed with a glass of water each morning

DIETARY_SUPPLEMENT

Placebo

Placebo 1 - stick pack of maltodextrin 1 mixed with a glass of water each morning

DIETARY_SUPPLEMENT

Treatment

Prebiotic 2 - Stick pack of combination 2 of two polysaccharides mixed with a glass of water each morning

DIETARY_SUPPLEMENT

Placebo

Placebo 2 - stick pack of maltodextrin 2 mixed with a glass of water each morning

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • Pharmavite LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-04-07
Completion
2025-06-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611215 on ClinicalTrials.gov