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Clinical Trials/NCT01109628
NCT01109628CompletedNot Applicable

Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Wageningen University1 site in 1 country65 target enrollmentStarted: November 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
1
Primary Endpoint
Change in skeletal muscle mass
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
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

Arms & Interventions

Protein drink

Experimental

Intervention: Protein drink (Dietary Supplement)

Placebo drink

Placebo Comparator

Intervention: Placebo drink (Dietary Supplement)

Outcomes

Primary Outcomes

Change in skeletal muscle mass

Time Frame: Baseline, 3 months and 6 months

Secondary Outcomes

  • Dietary intake(Baseline, 3 months and 6 months)
  • Physical performance(Baseline, 3 months and 6 months)
  • Blood parameters related to the outcome measures(Baseline, 3 months and 6 months)
  • Blood pressure(Baseline, 3 months and 6 months)
  • Physical activity(Baseline, 3 months and 6 months)
  • Cognitive performance(Baseline and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisette de Groot

Professor

Wageningen University

Study Sites (1)

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