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

R

Radoslaw Pach, MD, Ph D

Status and phase

Completed
Phase 3

Conditions

Elderly Infection
Nutritional Supplement Toxicity
Nutrition Disorders in Old Age

Treatments

Dietary Supplement: Nutridrink Multi Fibre

Study type

Interventional

Funder types

Other

Identifiers

NCT03588897
Nutrition in Elderly RCT

Details and patient eligibility

About

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 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.

Enrollment

120 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Normal Diet
No Intervention group
Description:
Elderly patients receiving normal diet
Nutritional Support
Experimental group
Description:
Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)
Treatment:
Dietary Supplement: Nutridrink Multi Fibre

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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