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Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly (ProMO)

Primary Purpose

Malnutrition, Muscle Health

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ONS
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 65+
  • at risk of malnutrition/ malnourished

Exclusion Criteria:

  • • Mental status that is incompatible with the proper conduct of the study

    • Illness of such severity that life expectancy is considered to be less than 12 months
    • Use of diabetes medication (e.g. insulin, methformin)
    • Use of an oral nutritional supplement in the previous three months
    • Participating in any regular exercise training program (≥2h/w)
    • Renal insufficiency (eGFR <30 mL/min/1.73 m2)
    • Unstable organ failure or organ failure necessitating a special diet
    • Chronic corticosteroids use
    • Recent (previous 2 months) use of antibiotics
    • Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
    • Recent blood donation (<1 month prior to Day 01 of the study)
    • Not willing or afraid to give blood during the study
    • Allergic or sensitive for milk proteins
    • Reported vegan or macrobiotic life-style
    • Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
    • Individual unable to give informed consent
    • Current participation in other research from the Division of Human Nutrition
    • Not having a general practitioner
    • Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives

Sites / Locations

  • Wageningen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ONS1

ONS2

Arm Description

new product

usual care

Outcomes

Primary Outcome Measures

lean body mass

Secondary Outcome Measures

body weight

Full Information

First Posted
February 12, 2016
Last Updated
July 20, 2016
Sponsor
Wageningen University
Collaborators
Vitalnext
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1. Study Identification

Unique Protocol Identification Number
NCT02683720
Brief Title
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Acronym
ProMO
Official Title
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University
Collaborators
Vitalnext

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Muscle Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ONS1
Arm Type
Experimental
Arm Description
new product
Arm Title
ONS2
Arm Type
Active Comparator
Arm Description
usual care
Intervention Type
Dietary Supplement
Intervention Name(s)
ONS
Intervention Description
randomized clinical trial involving different ONS strategies
Primary Outcome Measure Information:
Title
lean body mass
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 65+ at risk of malnutrition/ malnourished Exclusion Criteria: • Mental status that is incompatible with the proper conduct of the study Illness of such severity that life expectancy is considered to be less than 12 months Use of diabetes medication (e.g. insulin, methformin) Use of an oral nutritional supplement in the previous three months Participating in any regular exercise training program (≥2h/w) Renal insufficiency (eGFR <30 mL/min/1.73 m2) Unstable organ failure or organ failure necessitating a special diet Chronic corticosteroids use Recent (previous 2 months) use of antibiotics Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin) Recent blood donation (<1 month prior to Day 01 of the study) Not willing or afraid to give blood during the study Allergic or sensitive for milk proteins Reported vegan or macrobiotic life-style Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week) Individual unable to give informed consent Current participation in other research from the Division of Human Nutrition Not having a general practitioner Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
Facility Information:
Facility Name
Wageningen University
City
Wageningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pol Grootswagers, Msc
Email
pol.grootswagers@wur.nl
First Name & Middle Initial & Last Name & Degree
Lisette de Groot, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Pol Grootswagers, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33799307
Citation
Grootswagers P, Smeets E, Oteng AB, Groot L. A novel oral nutritional supplement improves gait speed and mitochondrial functioning compared to standard care in older adults with (or at risk of) undernutrition: results from a randomized controlled trial. Aging (Albany NY). 2021 Apr 2;13(7):9398-9418. doi: 10.18632/aging.202912. Epub 2021 Apr 2.
Results Reference
derived

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Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

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