The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Nutrition Disorders in Old Age
- Sponsor
- Radoslaw Pach, MD, Ph D
- Enrollment
- 120
- Primary Endpoint
- Prealbumin plasma concentration
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Radoslaw Pach, MD, Ph D
Assisstant Professor
Jagiellonian University
Eligibility Criteria
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
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
TLC
Time Frame: 2 months
Total lymphocyte count two months after start of the intervention
BMI of the elderly patients
Time Frame: 2 months
BMI two months after start of the intervention
Transferrin plasma concentration
Time Frame: 2 months
Transferrin concentration two months after start of the intervention
Secondary Outcomes
- Functional status of the patient - Barthel's scale(2 months)
- Organ infections(2 months)
- Complications(2 months)
- Functional status of the patient - MMSE scale(2 months)