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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683720
Recruitment Status : Unknown
Verified July 2016 by Lisette de Groot, Wageningen University.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
Vitalnext
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University

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.

Condition or disease Intervention/treatment Phase
Malnutrition Muscle Health Dietary Supplement: ONS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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




Primary Outcome Measures :
  1. lean body mass [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. body weight [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683720


Locations
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Netherlands
Wageningen University Recruiting
Wageningen, Netherlands
Contact: Pol Grootswagers, Msc       pol.grootswagers@wur.nl   
Principal Investigator: Lisette de Groot, Prof. Dr.         
Sub-Investigator: Pol Grootswagers, MSc         
Sponsors and Collaborators
Wageningen University
Vitalnext
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Responsible Party: Lisette de Groot, MSc PhD Prof, Wageningen University
ClinicalTrials.gov Identifier: NCT02683720    
Other Study ID Numbers: NL56873.081.16
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders