The Impact of Oral Nutritional Supplements on the Nutritional Status of Elderly Patients

The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.

The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.

Study Overview

• Status: Completed
• Conditions: Elderly Infection; Nutrition Disorders in Old Age; Nutritional Supplement Toxicity
• Intervention / Treatment: Dietary supplement: Nutridrink Multi Fibre

Detailed Description

The aim of the study was to compare nutritional status of two groups of elderly patients (> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:

• functional status of the patient (Barthel's scale, MMSE scale)
• nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.

The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age > 65 and general status which enables compliance with study requirements
• Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
• MMSE (Mini Mental State Examination) points 24-30
• no use of laxatives

Exclusion Criteria:

• lack of consent
• neoplasms
• previous enteral nutrition
• Barthel's scale 0-20
• MMSE points 0-23
• BMI > 25
• laxatives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal Diet; Elderly patients receiving normal diet
Experimental: Nutritional Support; Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)	Dietary supplement: Nutridrink Multi Fibre; Dietary supplementation of 300 kcal for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI of the elderly patients	BMI two months after start of the intervention	2 months
Prealbumin plasma concentration	Prealbumin concentration two months after start of the intervention	2 months
Albumin plasma concentration	Albumin concentration two months after start of the intervention	2months
Transferrin plasma concentration	Transferrin concentration two months after start of the intervention	2 months
TLC	Total lymphocyte count two months after start of the intervention	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ infections	Infection in any organ based on clinical data	2 months
Complications	Any complications associated with nutritional support	2 months
Functional status of the patient - Barthel's scale	Scores in Barthel's scale two months after start of the intervention	2 months
Functional status of the patient - MMSE scale	Scores in MMSE scale two months after start of the intervention	2 months

Collaborators and Investigators

• Sponsor: Radoslaw Pach, MD, Ph D
• Investigators: Principal Investigator: Lucyna Scislo, MD PhD, Department of Clinical Nursery, Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 15, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: nutritional status; Nutridrink; elderly nutrition
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: Nutrition in Elderly RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No