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

NCT ID: NCT03588897

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Nutrition Disorders in Old Age Nutritional Supplement Toxicity Elderly Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Normal diet versus normal diet + nutritional support in elderly patients
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Normal Diet

Elderly patients receiving normal diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Nutritional Support

Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)

Group Type EXPERIMENTAL

Nutridrink Multi Fibre

Intervention Type DIETARY_SUPPLEMENT

Dietary supplementation of 300 kcal for 14 days

Interventions

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Nutridrink Multi Fibre

Dietary supplementation of 300 kcal for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radoslaw Pach, MD, Ph D

OTHER

Sponsor Role lead

Responsible Party

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Radoslaw Pach, MD, Ph D

Assisstant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lucyna Scislo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Nursery, Jagiellonian University

Other Identifiers

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Nutrition in Elderly RCT

Identifier Type: -

Identifier Source: org_study_id

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