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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02683720

Acronym

ProMO

Enrollment

Registered

2016-02-17

Start date

2016-07-31

Completion date

2017-12-31

Last updated

2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Muscle Health

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.

Interventions

DIETARY_SUPPLEMENTONS

randomized clinical trial involving different ONS strategies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
lean body mass	12 weeks

Secondary

Measure	Time frame
body weight	12 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026