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

Not Applicable

• Conditions: Malnutrition; Muscle Health
• Interventions: Dietary Supplement: ONS

• 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

Arm && Interventions

Group	Intervention	Description
ONS2	ONS	usual care
ONS1	ONS	new product

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