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Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People (ProMuscle)

This study has been completed.
Maastricht University Medical Center
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University Identifier:
First received: February 12, 2010
Last updated: January 30, 2012
Last verified: January 2012

The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.

Condition Intervention
Dietary Supplement: Protein drink
Dietary Supplement: Placebo drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Change in skeletal muscle mass [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical performance [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Blood parameters related to the outcome measures [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Cognitive performance [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein drink Dietary Supplement: Protein drink
Twice a day during 6 months
Placebo Comparator: Placebo drink Dietary Supplement: Placebo drink
Twice a day during 6 months


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Frail elderly individuals
  • Able to understand and perform the study procedures

Exclusion Criteria:

  • Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
  • No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
  • Use of anti-coagulation medication (except of Acetyl Salicyl acid)
  • Renal insufficiency (eGFR <60 mL/min/1.73 m2)
  • Allergic or sensitive for milk proteins
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Please refer to this study by its identifier: NCT01109628

Wageningen University
Wageningen, Gelderland, Netherlands, 6703HD
Sponsors and Collaborators
Wageningen University
Maastricht University Medical Center
Top Institute Food and Nutrition
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lisette de Groot, Professor, Wageningen University Identifier: NCT01109628     History of Changes
Other Study ID Numbers: A1002-1
Study First Received: February 12, 2010
Last Updated: January 30, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
frail elderly
protein drink
skeletal muscle mass
muscle mass in elderly

Additional relevant MeSH terms:
Muscular Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms processed this record on November 23, 2014