Clinical trial NCT05257980: Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
Official title: Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compliance with ONS prescription
timeFrame: Baseline (Day 1) - End of the study (Day 29)
Secondary outcomes:
measure: Nutrient Intake
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Acceptability
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Gastrointestinal Tolerance
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Anthropometry
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Nutritional Status
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Dietetic Goal
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Appetite
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Appetite (SNAQ)
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Medical and Dietetic History
timeFrame: Baseline (Day 1) - End of the study (Day 29)
measure: Adverse Events
timeFrame: Baseline (Day 1) - End of the study (Day 29)
Other outcomes:
Locations:
city: Ashford
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: West Walk Surgery
city: Chippenham
country: United Kingdom
facility: Rowden Surgery
city: Clevedon
country: United Kingdom
facility: Sirona Care & Health
city: Dumfries
country: United Kingdom
facility: Mountainhall Treatment Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
city: Harrow
country: United Kingdom
facility: Preston Hill Surgery
city: Honiton
country: United Kingdom
facility: Honiton Surgery
city: Hull
country: United Kingdom
facility: James Alexander Family Practice
city: Inverness
country: United Kingdom
facility: NHS Highland
city: Keighley
country: United Kingdom
facility: Airedale NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings Cross Hospital
city: Newcastle
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Rhyl
country: United Kingdom
facility: Glan Clwyd Hospital
city: Trowbridge
country: United Kingdom
facility: Trowbridge Health Centre
city: Waterlooville
country: United Kingdom
facility: Cowplain Family Practice
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
Study officials:
affiliation: Nutricia Ltd
name: Rebecca Stratton, PhD
role: STUDY_CHAIR
References: