A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People (ProMuscle)

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ClinicalTrials.gov Identifier: NCT01110369

Recruitment Status : Completed

First Posted : April 26, 2010

Last Update Posted : January 31, 2012

Sponsor:

Collaborators:

Top Institute Food and Nutrition

Maastricht University Medical Center

Information provided by (Responsible Party):

Lisette de Groot, Wageningen University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sarcopenia	Dietary Supplement: Protein drink Other: Resistance exercise training Dietary Supplement: Placebo drink	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People
Study Start Date :	November 2009
Actual Primary Completion Date :	July 2011
Actual Study Completion Date :	July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Resistance exercise training and protein drink	Dietary Supplement: Protein drink Protein drink twice a day during 6 months. Other: Resistance exercise training Resistance exercise training twice per week during 6 months.
Placebo Comparator: Resistance exercise training and placebo drink	Other: Resistance exercise training Resistance exercise training twice per week during 6 months. Dietary Supplement: Placebo drink Placebo drink twice a day during 6 months.

Outcome Measures

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 will be collected to assess 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	65 Years and older (Older Adult)
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)
Presence of coronary heart disease (ECG)
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): NCT01110369

Locations

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Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6703HD

Sponsors and Collaborators

Wageningen University

Top Institute Food and Nutrition

Maastricht University Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.

Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6.

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Responsible Party:	Lisette de Groot, Professor, Wageningen University
ClinicalTrials.gov Identifier:	NCT01110369 History of Changes
Other Study ID Numbers:	A1002-2
First Posted:	April 26, 2010 Key Record Dates
Last Update Posted:	January 31, 2012
Last Verified:	January 2012

Keywords provided by Lisette de Groot, Wageningen University:


sarcopenia frail elderly protein drink	resistance exercise Skeletal muscle mass muscle mass in elderly

Additional relevant MeSH terms:

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Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations	Nervous System Diseases Atrophy Pathological Conditions, Anatomical Signs and Symptoms

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