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

Study Overview
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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.

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

Conditions
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Nutrition Disorders in Old Age, Nutritional Supplement Toxicity, Elderly Infection

Intervention / Treatment
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* Dietary Supplement: Nutridrink Multi Fibre


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Normal diet versus normal diet + nutritional support in elderly patients
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional status, Nutridrink, elderly nutrition