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

Elderly Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588897
• Other study ID #: Nutrition in Elderly RCT
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly Infection
• Nutrition Disorders
• Nutrition Disorders in Old Age
• Nutritional Supplement Toxicity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radoslaw Pach, MD, Ph D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI of the elderly patients	BMI two months after start of the intervention	2 months
Primary	Prealbumin plasma concentration	Prealbumin concentration two months after start of the intervention	2 months
Primary	Albumin plasma concentration	Albumin concentration two months after start of the intervention	2months
Primary	Transferrin plasma concentration	Transferrin concentration two months after start of the intervention	2 months
Primary	TLC	Total lymphocyte count two months after start of the intervention	2 months
Secondary	Organ infections	Infection in any organ based on clinical data	2 months
Secondary	Complications	Any complications associated with nutritional support	2 months
Secondary	Functional status of the patient - Barthel's scale	Scores in Barthel's scale two months after start of the intervention	2 months
Secondary	Functional status of the patient - MMSE scale	Scores in MMSE scale two months after start of the intervention	2 months