Evaluation of Four New Ready to Drink Oral Nutritional Supplements for the Management of Disease-related Malnutrition in Adults.

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Ashford
West Walk Surgery
ACTIVE_NOT_RECRUITING
Bristol
Rowden Surgery
ACTIVE_NOT_RECRUITING
Chippenham
Sirona Care & Health
ACTIVE_NOT_RECRUITING
Clevedon
Mountainhall Treatment Centre
ACTIVE_NOT_RECRUITING
Dumfries
Royal Surrey NHS Foundation Trust
RECRUITING
Guildford
Preston Hill Surgery
ACTIVE_NOT_RECRUITING
Harrow
Honiton Surgery
RECRUITING
Honiton
James Alexander Family Practice
ACTIVE_NOT_RECRUITING
Hull
NHS Highland
ACTIVE_NOT_RECRUITING
Inverness
Airedale NHS Foundation Trust
RECRUITING
Keighley
Kings Cross Hospital
ACTIVE_NOT_RECRUITING
London
Northumbria Healthcare NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Newcastle
Norfolk Community Health and Care NHS Trust
RECRUITING
Norwich
Nottingham University Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Nottingham
Glan Clwyd Hospital
ACTIVE_NOT_RECRUITING
Rhyl
Trowbridge Health Centre
ACTIVE_NOT_RECRUITING
Trowbridge
Cowplain Family Practice
RECRUITING
Waterlooville
Yeovil District Hospital
ACTIVE_NOT_RECRUITING
Yeovil
Contact Information
Primary
Marta Delsoglio
marta.delsoglio@nutricia.com
+447920530707
Backup
Corbin Griffen
corbin.griffen@nutricia.com
Time Frame
Start Date: 2021-09-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Dietary supplement (ONS)
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.
Related Therapeutic Areas
Sponsors
Leads: Nutricia UK Ltd

This content was sourced from clinicaltrials.gov