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

Not Applicable

• Conditions: Malnutrition; Muscle Health

• Registration Number: NCT02683720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-17
• Status Verified: 2016-07
• Study Start: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
lean body mass	12 weeks

Secondary Outcome Measures

Name	Time	Method
body weight	12 weeks

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Netherlands