MedTrace Logo

Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota in Older Adults with or At Risk of Disease Related Malnutrition

NCT06645171 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-10-16

No results posted yet for this study

Summary

This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).

Conditions

  • Changes in Gut Microbiota Bifidobacterial Levels

Interventions

DIETARY_SUPPLEMENT

Fibre drink

One drink will be tested

Sponsors & Collaborators

  • Nutricia Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-12-31
Completion
2026-12-31

More Related Trials

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 NCT06645171 on ClinicalTrials.gov