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

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.

Full Title of Study: “The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly – Randomised Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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 2×100 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.

Interventions

  • Dietary Supplement: Nutridrink Multi Fibre
    • Dietary supplementation of 300 kcal for 14 days

Arms, Groups and Cohorts

  • No Intervention: Normal Diet
    • Elderly patients receiving normal diet
  • Experimental: Nutritional Support
    • Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2×100 ml per day)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Organ infections
    • Time Frame: 2 months
    • Infection in any organ based on clinical data
  • Complications
    • Time Frame: 2 months
    • Any complications associated with nutritional support
  • Functional status of the patient – Barthel’s scale
    • Time Frame: 2 months
    • Scores in Barthel’s scale two months after start of the intervention
  • Functional status of the patient – MMSE scale
    • Time Frame: 2 months
    • Scores in MMSE scale two months after start of the intervention

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radoslaw Pach, MD, Ph D
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Radoslaw Pach, MD, Ph D, Assisstant Professor – Jagiellonian University
  • Overall Official(s)
    • Lucyna Scislo, MD PhD, Principal Investigator, Department of Clinical Nursery, Jagiellonian University

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