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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03588897
Enrollment
120
Registered
2018-07-17
Start date
2014-01-31
Completion date
2018-06-30
Last updated
2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

nutritional status, Nutridrink, elderly nutrition

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.

Interventions

DIETARY_SUPPLEMENTNutridrink Multi Fibre

Dietary supplementation of 300 kcal for 14 days

Sponsors

Radoslaw Pach, MD, Ph D
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Normal diet versus normal diet + nutritional support in elderly patients

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TLC2 monthsTotal lymphocyte count two months after start of the intervention
BMI of the elderly patients2 monthsBMI two months after start of the intervention
Prealbumin plasma concentration2 monthsPrealbumin concentration two months after start of the intervention
Albumin plasma concentration2monthsAlbumin concentration two months after start of the intervention
Transferrin plasma concentration2 monthsTransferrin concentration two months after start of the intervention

Secondary

MeasureTime frameDescription
Complications2 monthsAny complications associated with nutritional support
Functional status of the patient - Barthel's scale2 monthsScores in Barthel's scale two months after start of the intervention
Functional status of the patient - MMSE scale2 monthsScores in MMSE scale two months after start of the intervention
Organ infections2 monthsInfection in any organ based on clinical data

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026