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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109628
First Posted: April 23, 2010
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Maastricht University Medical Center
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Lisette de Groot, Wageningen University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Lisette de Groot, Wageningen University:

Primary Outcome Measures:
  • Change in skeletal muscle mass [ Time Frame: Baseline, 3 months and 6 months ]

Secondary Outcome Measures:
  • Physical performance [ Time Frame: Baseline, 3 months and 6 months ]
  • Blood parameters related to the outcome measures [ Time Frame: Baseline, 3 months and 6 months ]
  • Dietary intake [ Time Frame: Baseline, 3 months and 6 months ]
  • Physical activity [ Time Frame: Baseline, 3 months and 6 months ]
  • Cognitive performance [ Time Frame: Baseline and 6 months ]
  • Blood pressure [ Time Frame: Baseline, 3 months and 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 12, 2010
First Posted: April 23, 2010
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Lisette de Groot, 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