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

NCT05257980 | Active Not Recruiting

• 1 other identifier: ONS2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (1)

• Compliance with ONS prescription

  Compliance with ONS prescription (% of bottle and how many bottles consumed) will be assessed daily by recording how much of the product was prescribed, compared to the amount consumed by the patient. The amount prescribed by the investigating dietitian/nurse will be recorded at the start of the study and any changes to this prescription will also be noted. For patients already receiving an ONS prior to enrolling onto the study, compliance will be assessed for 1 day at baseline. For all patients, compliance with the intervention ONS prescription will be assessed daily throughout the study and will be recorded by the patient/carer. For analysis, the mean daily % and the mean daily number of bottles consumed over the 28 days will be used.

  Baseline (Day 1) - End of the study (Day 29)

Secondary Outcomes (10)

• Nutrient Intake

  Baseline (Day 1) - End of the study (Day 29)

• Acceptability

  Baseline (Day 1) - End of the study (Day 29)

• Gastrointestinal Tolerance

  Baseline (Day 1) - End of the study (Day 29)

• Anthropometry

  Baseline (Day 1) - End of the study (Day 29)

• Nutritional Status

  Baseline (Day 1) - End of the study (Day 29)

Study Arms (1)

Dietary supplement (ONS)

EXPERIMENTAL

All patients will receive standardised dietary advice in addition to the ONS prescribed daily for 28 days. 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 ONS prescribed will be the same throughout the 28 days and will be taken orally.

Dietary Supplement: Dietary supplement (ONS)

Interventions

Dietary supplement (ONS) DIETARY_SUPPLEMENT

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.

Dietary supplement (ONS)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• ≥16 years of age
• Identified as being malnourished/at risk of malnutrition by malnutrition screening tools \[i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan\]
• Expected to receive at least one bottle of ONS per day
• Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign

You may not qualify if:

• Patients receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
• Patients with major hepatic dysfunction (i.e., decompensated liver disease)
• Patients with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
• Cancer patients likely to anticipate significant gastrointestinal disturbances/taste changes as a result of Systemic Anti-Cancer Therapy (SACT)
• Patients with active/chronic gastrointestinal disease or impaired gastrointestinal function
• Patients with significant dysphagia/high aspiration risk
• Participation in other clinical intervention studies within 1 month of this study
• Adults lacking mental capacity to consent
• Allergy to any study product ingredients
• Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (19)

Ashford and St Peter's Hospitals NHS Foundation Trust

Ashford, United Kingdom

Location

West Walk Surgery

Bristol, United Kingdom

Location

Rowden Surgery

Chippenham, United Kingdom

Location

Sirona Care & Health

Clevedon, United Kingdom

Location

Mountainhall Treatment Centre

Dumfries, United Kingdom

Location

Royal Surrey NHS Foundation Trust

Guildford, United Kingdom

Location

Preston Hill Surgery

Harrow, United Kingdom

Location

Honiton Surgery

Honiton, United Kingdom

Location

James Alexander Family Practice

Hull, United Kingdom

Location

NHS Highland

Inverness, United Kingdom

Location

Airedale NHS Foundation Trust

Keighley, United Kingdom

Location

Kings Cross Hospital

London, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Newcastle, United Kingdom

Location

Norfolk Community Health and Care NHS Trust

Norwich, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, United Kingdom

Location

Trowbridge Health Centre

Trowbridge, United Kingdom

Location

Cowplain Family Practice

Waterlooville, United Kingdom

Location

Yeovil District Hospital

Yeovil, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rebecca Stratton, PhD

  Nutricia Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: February 25, 2022
• Study Start: September 27, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (19)