Protein Top-up Acceptability Study for Patients With Increased Protein Needs

NCT04607330 | Completed

• 1 other identifier: PROSHT20'
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this prospective, single-arm intervention study is to evaluate the acceptability (compliance, gastrointestinal tolerance, and palatability) to a low calorie, low volume, ready to use, high protein liquid in patients with elevated protein needs.

Conditions

Cancer; Neurological Injury; Respiratory Disease; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Acceptability

  Acceptability of the patients existing feeding regimen (including any protein module use) will be assessed on day 1, baseline period. Acceptability with the study product will be assessed at the end of the intervention period using a standardised questionnaire completed by the patient.

  2 days (days 1 and 29)

Secondary Outcomes (10)

• Compliance

  29 days

• Change in Gastrointestinal tolerance

  4 days (day 1, 8, 15 and 29)

• Change in Nutrient Intake (24-hour dietary recall)

  2 days (day 1 and 29)

• Change in Physical Function (30-s Chair Stand Test)

  2 days (day 1 and 29)

• Change in MUST Screening

  2 days (day 1 and 29)

Study Arms (1)

High protein liquid

EXPERIMENTAL

A ready to use, low calorie, low volume, ready to use, high protein liquid modular (HPLM) feed for adults.

Other: High protein liquid

Interventions

High protein liquid OTHER

After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.

High protein liquid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older.
• Patients under the care of a Dietitian requiring oral or enteral nutritional support, with -increased protein needs.
• To receive a minimum of 1 x 40ml HPLM daily (orally or via enteral tube) while on the study.
• Informed consent obtained from the patient

You may not qualify if:

• Total parenteral nutrition (100% of requirements).
• 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)).
• Participation in other studies within 1 month prior to entry of this study.
• Patient with severe lactose intolerance.
• Pregnant or lactating.
• Patient lacks capacity to consent for themselves.

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (2)

Western Sussex Hospitals NHS Trust

Worthing, West Sussex, BN11 2DH, United Kingdom

Location

University Hospitals Bristol

Bristol, BS2 8HW, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Trauma, Nervous System; Respiration Disorders; Stroke

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Respiratory Tract Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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

Model Details: Single-arm intervention study to evaluate the acceptability (compliance, gastrointestinal tolerance and palatability) of the high protein liquid feed in patients with elevated protein needs.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 29, 2020
• Study Start: October 28, 2020
• Primary Completion: May 30, 2022
• Study Completion: June 28, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

GB (2)