NCT06645171

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

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 Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Fibre drink	One drink will be tested

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-10-16
• Last updated: 2024-10-16