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

Last updated: February 24, 2025
Sponsor: Nutricia UK Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

Dietary supplement (ONS)

Clinical Study ID

NCT05257980
ONS2021
  • Ages > 16
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • ≥16 years of age

  • Identified as being malnourished/at risk of malnutrition by malnutrition screeningtools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily aspart 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 consentcountersigned by a witness for those physically unable to sign

Exclusion

Exclusion Criteria:

  • Patients receiving parenteral nutrition or ≥70% total energy requirements fromenteral tube feeding

  • Patients with major hepatic dysfunction (i.e., decompensated liver disease)

  • Patients with major renal dysfunction [i.e., requiring filtration or stage 4/5chronic kidney disease (CKD)]

  • Cancer patients likely to anticipate significant gastrointestinal disturbances/tastechanges as a result of Systemic Anti-Cancer Therapy (SACT)

  • Patients with active/chronic gastrointestinal disease or impaired gastrointestinalfunction

  • 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 thestudy requirements.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Dietary supplement (ONS)
Phase:
Study Start date:
September 27, 2021
Estimated Completion Date:
December 31, 2026

Study Description

Disease-related malnutrition (DRM) is a highly prevalent condition which leads to significant adverse health and economic burden. For the management of patients with DRM, oral nutritional supplements (ONS) are recommended and often prescribed (typically 1-3/day). ONS are energy- and nutrient-dense feeds that provide macro and micro-nutrients, designed to increase nutritional intake when diet alone is insufficient to meet daily nutritional requirements. The use of ONS has been shown to be effective for managing DRM by improving patient outcomes, including alleviating disease symptoms, aiding recovery from illness, regaining strength and improving quality of life, and reducing mortality. Additionally, the use of ONS has been reported to be cost effective in the healthcare setting due to reduced complications, fewer hospitalisations, and a reduced length of hospital stay.

An important outcome to enable ONS to be clinically and physiologically effective is compliance (i.e., how much the patient consumes relative to what is prescribed). Whilst good compliance to ONS in both hospital and community patients has been reported (78%), compliance in some patient groups has been reported to be as low as 35%. Poor compliance has been reported due to inability to consume the required volume, poor palatability, and taste fatigue. Furthermore, with increasing trends in plant-based food consumption and veganism, the lack of plant-based ONS may reduce compliance in vegan patients or those wishing to reduce animal-derived consumption for cultural or religious reasons. Consequently, there is a clear need for the development of different types of ONS which better cater both for patients with reported low compliance, but also patients with potentially higher compliance when presented with increased variety and choice.

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.

Connect with a study center

  • Ashford and St Peter's Hospitals NHS Foundation Trust

    Ashford,
    United Kingdom

    Site Not Available

  • West Walk Surgery

    Bristol,
    United Kingdom

    Site Not Available

  • Rowden Surgery

    Chippenham,
    United Kingdom

    Site Not Available

  • Sirona Care & Health

    Clevedon,
    United Kingdom

    Site Not Available

  • Mountainhall Treatment Centre

    Dumfries,
    United Kingdom

    Site Not Available

  • Royal Surrey NHS Foundation Trust

    Guildford,
    United Kingdom

    Active - Recruiting

  • Preston Hill Surgery

    Harrow,
    United Kingdom

    Site Not Available

  • Honiton Surgery

    Honiton,
    United Kingdom

    Active - Recruiting

  • James Alexander Family Practice

    Hull,
    United Kingdom

    Site Not Available

  • NHS Highland

    Inverness,
    United Kingdom

    Site Not Available

  • Airedale NHS Foundation Trust

    Keighley,
    United Kingdom

    Active - Recruiting

  • Kings Cross Hospital

    London,
    United Kingdom

    Site Not Available

  • Northumbria Healthcare NHS Foundation Trust

    Newcastle,
    United Kingdom

    Site Not Available

  • Norfolk Community Health and Care NHS Trust

    Norwich,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham,
    United Kingdom

    Site Not Available

  • Glan Clwyd Hospital

    Rhyl,
    United Kingdom

    Site Not Available

  • Trowbridge Health Centre

    Trowbridge,
    United Kingdom

    Site Not Available

  • Cowplain Family Practice

    Waterlooville,
    United Kingdom

    Active - Recruiting

  • Yeovil District Hospital

    Yeovil,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.