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

NCT03588897 | Completed Phase 3

• 1 other identifier: Nutrition in Elderly RCT
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

nutritional status; Nutridrink; elderly nutrition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Organ infections

  2 months

• Complications

  2 months

• Functional status of the patient - Barthel's scale

  2 months

• Functional status of the patient - MMSE scale

  2 months

Study Arms (2)

Normal Diet

NO INTERVENTION

Elderly patients receiving normal diet

Nutritional Support

EXPERIMENTAL

Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)

Dietary Supplement: Nutridrink Multi Fibre

Interventions

Nutridrink Multi Fibre DIETARY_SUPPLEMENT

Dietary supplementation of 300 kcal for 14 days

Nutritional Support

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• lack of consent
• neoplasms
• previous enteral nutrition
• Barthel's scale 0-20
• MMSE points 0-23
• BMI \> 25
• laxatives

Sponsors & Collaborators

• Radoslaw Pach, MD, Ph D: lead

Study Officials

• Lucyna Scislo, MD PhD

  Department of Clinical Nursery, Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant Professor

Model Details: Normal diet versus normal diet + nutritional support in elderly patients

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 17, 2018
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share