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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nutridrink Multi Fibre
Sponsored by
Radoslaw Pach, MD, Ph D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorders in Old Age focused on measuring nutritional status, Nutridrink, elderly nutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Normal Diet

    Nutritional Support

    Arm Description

    Elderly patients receiving normal diet

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

    Outcomes

    Primary Outcome Measures

    BMI of the elderly patients
    BMI two months after start of the intervention
    Prealbumin plasma concentration
    Prealbumin concentration two months after start of the intervention
    Albumin plasma concentration
    Albumin concentration two months after start of the intervention
    Transferrin plasma concentration
    Transferrin concentration two months after start of the intervention
    TLC
    Total lymphocyte count two months after start of the intervention

    Secondary Outcome Measures

    Organ infections
    Infection in any organ based on clinical data
    Complications
    Any complications associated with nutritional support
    Functional status of the patient - Barthel's scale
    Scores in Barthel's scale two months after start of the intervention
    Functional status of the patient - MMSE scale
    Scores in MMSE scale two months after start of the intervention

    Full Information

    First Posted
    July 1, 2018
    Last Updated
    July 15, 2018
    Sponsor
    Radoslaw Pach, MD, Ph D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03588897
    Brief Title
    The Impact of Oral Nutritional Supplements on the Nutritional Status of Elderly Patients
    Official Title
    The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Radoslaw Pach, MD, Ph D

    4. Oversight

    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Disorders in Old Age, Nutritional Supplement Toxicity, Elderly Infection
    Keywords
    nutritional status, Nutridrink, elderly nutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Normal diet versus normal diet + nutritional support in elderly patients
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Diet
    Arm Type
    No Intervention
    Arm Description
    Elderly patients receiving normal diet
    Arm Title
    Nutritional Support
    Arm Type
    Experimental
    Arm Description
    Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutridrink Multi Fibre
    Intervention Description
    Dietary supplementation of 300 kcal for 14 days
    Primary Outcome Measure Information:
    Title
    BMI of the elderly patients
    Description
    BMI two months after start of the intervention
    Time Frame
    2 months
    Title
    Prealbumin plasma concentration
    Description
    Prealbumin concentration two months after start of the intervention
    Time Frame
    2 months
    Title
    Albumin plasma concentration
    Description
    Albumin concentration two months after start of the intervention
    Time Frame
    2months
    Title
    Transferrin plasma concentration
    Description
    Transferrin concentration two months after start of the intervention
    Time Frame
    2 months
    Title
    TLC
    Description
    Total lymphocyte count two months after start of the intervention
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Organ infections
    Description
    Infection in any organ based on clinical data
    Time Frame
    2 months
    Title
    Complications
    Description
    Any complications associated with nutritional support
    Time Frame
    2 months
    Title
    Functional status of the patient - Barthel's scale
    Description
    Scores in Barthel's scale two months after start of the intervention
    Time Frame
    2 months
    Title
    Functional status of the patient - MMSE scale
    Description
    Scores in MMSE scale two months after start of the intervention
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lucyna Scislo, MD PhD
    Organizational Affiliation
    Department of Clinical Nursery, Jagiellonian University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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