Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
ProMO
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 21, 2016
July 1, 2016
1.4 years
February 12, 2016
July 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
lean body mass
12 weeks
Secondary Outcomes (1)
body weight
12 weeks
Study Arms (2)
ONS1
EXPERIMENTALnew product
ONS2
ACTIVE COMPARATORusual care
Interventions
Eligibility Criteria
You may qualify if:
- age 65+
- at risk of malnutrition/ malnourished
You may not qualify if:
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Vitalnextcollaborator
Study Sites (1)
Wageningen University
Wageningen, Netherlands
Related Publications (1)
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.
PMID: 33799307DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc PhD Prof
Study Record Dates
First Submitted
February 12, 2016
First Posted
February 17, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 21, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share