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

Phase 3

Completed

• Conditions: Elderly Infection; Nutrition Disorders in Old Age; Nutritional Supplement Toxicity

• Registration Number: NCT03588897
• Lead Sponsor: Radoslaw Pach, MD, Ph D

Brief Summary

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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2018-06
• Status Verified: 2018-07
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-15
• Last Update Submitted: 2018-07-15
• Study First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prealbumin plasma concentration	2 months	Prealbumin concentration two months after start of the intervention
Albumin plasma concentration	2months	Albumin concentration two months after start of the intervention
TLC	2 months	Total lymphocyte count two months after start of the intervention
BMI of the elderly patients	2 months	BMI two months after start of the intervention
Transferrin plasma concentration	2 months	Transferrin concentration two months after start of the intervention

Secondary Outcome Measures

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