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

Malnutrition Clinical Trial

— ProMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683720
• Other study ID #: NL56873.081.16
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2016
• Last updated: July 20, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Muscle Health

Intervention

Dietary Supplement:
• ONS
randomized clinical trial involving different ONS strategies

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Vitalnext

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass		12 weeks	No
Secondary	body weight		12 weeks	No