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

This study has been completed.
Sponsor:
Collaborators:
Maastricht University Medical Center
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
ClinicalTrials.gov Identifier:
NCT01109628
First received: February 12, 2010
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention
Sarcopenia
 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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109628

Locations
Netherlands
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lisette de Groot, Professor, Wageningen University
ClinicalTrials.gov 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:
sarcopenia
frail elderly
protein drink
skeletal muscle mass
muscle mass in elderly

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013