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

Wageningen University

Status

Unknown

Conditions

Malnutrition

Muscle Health

Treatments

Dietary Supplement: ONS

Study type

Interventional

Funder types

Other

Identifiers

NCT02683720

NL56873.081.16

Details and patient eligibility

About

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.

Enrollment

82 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts 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