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

July 20, 2016 updated by: Lisette de Groot, Wageningen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands
        • Recruiting
        • Wageningen University
        • Contact:
        • Principal Investigator:
          • Lisette de Groot, Prof. Dr.
        • Sub-Investigator:
          • Pol Grootswagers, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONS1
new product
Dietary supplement: ONS
randomized clinical trial involving different ONS strategies
Active Comparator: ONS2
usual care
Dietary supplement: ONS
randomized clinical trial involving different ONS strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lean body mass
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
body weight
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Vitalnext

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL56873.081.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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