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Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01109628
Acronym
ProMuscle
Enrollment
65
Registered
2010-04-23
Start date
2009-11-30
Completion date
2011-07-31
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

sarcopenia, frail elderly, protein drink, skeletal muscle mass, muscle mass in elderly

Brief summary

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

Interventions

DIETARY_SUPPLEMENTProtein drink

Twice a day during 6 months

DIETARY_SUPPLEMENTPlacebo drink

Twice a day during 6 months

Sponsors

Maastricht University Medical Center
CollaboratorOTHER
Top Institute Food and Nutrition
CollaboratorOTHER
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Change in skeletal muscle massBaseline, 3 months and 6 months

Secondary

MeasureTime frame
Blood parameters related to the outcome measuresBaseline, 3 months and 6 months
Dietary intakeBaseline, 3 months and 6 months
Physical performanceBaseline, 3 months and 6 months
Cognitive performanceBaseline and 6 months
Blood pressureBaseline, 3 months and 6 months
Physical activityBaseline, 3 months and 6 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026