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

Radoslaw Pach, MD, Ph D120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Nutrition Disorders in Old Age Nutritional Supplement Toxicity Elderly Infection

Interventions

Nutridrink Multi FibreDIETARY_SUPPLEMENT

Dietary supplementation of 300 kcal for 14 days

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

BMI of the elderly patients

BMI two months after start of the intervention

Time frame: 2 months

Prealbumin plasma concentration

Prealbumin concentration two months after start of the intervention

Time frame: 2 months

Albumin plasma concentration

Albumin concentration two months after start of the intervention

Time frame: 2months

Transferrin plasma concentration

Transferrin concentration two months after start of the intervention

Time frame: 2 months

TLC

Total lymphocyte count two months after start of the intervention

Time frame: 2 months

Secondary Outcomes

Organ infections

Infection in any organ based on clinical data

Time frame: 2 months

Complications

Any complications associated with nutritional support

Time frame: 2 months

Functional status of the patient - Barthel's scale

Scores in Barthel's scale two months after start of the intervention

Time frame: 2 months

Functional status of the patient - MMSE scale

Scores in MMSE scale two months after start of the intervention

Data from ClinicalTrials.gov

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