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Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial

NCT05257980 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-14

No results posted yet for this study

Summary

The aim of this study is to evaluate compliance, acceptability, gastrointestinal tolerance, nutrient intake, appetite, nutritional status, and safety of four new ready to drink ONS. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive one of the four ONS for 28 days alongside their routine diet.

Conditions

  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Dietary supplement (ONS)

At baseline, the investigating dietitian/nurse will record several measures, including clinical history and symptoms over the previous 24 hours. In addition, patients who are already receiving an ONS will continue their prescribed ONS for 1 day in which their gastrointestinal tolerance, ONS compliance and acceptability will be recorded. All patients will then receive standardised dietary advice in addition to one of the four trial ONS products daily for 28 days. The type of ONS will be agreed with the patient and the investigating dietitian/nurse, and the ONS prescription will be determined on an individual basis by the investigating dietitian/nurse responsible for the patient's nutritional management (1-3 ONS per day; aligned with guidelines set out within the Malnutrition Pathway). The type of ONS prescribed will be the same throughout the 28 days and will be taken orally.

Sponsors & Collaborators

  • Nutricia UK Ltd

    lead INDUSTRY

Principal Investigators

  • Rebecca Stratton, PhD · Nutricia Ltd

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United Kingdom

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 NCT05257980 on ClinicalTrials.gov