Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Sarcopenia Clinical Trial

— ProMuscle  

Official title:

Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109628
• Other study ID #: A1002-1
• Status: Completed
• Phase: N/A
• First received: February 12, 2010
• Last updated: January 30, 2012
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Protein drink
Twice a day during 6 months
• Placebo drink
Twice a day during 6 months

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Maastricht University Medical Center, Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skeletal muscle mass		Baseline, 3 months and 6 months	No
Secondary	Physical performance		Baseline, 3 months and 6 months	No
Secondary	Blood parameters related to the outcome measures		Baseline, 3 months and 6 months	No
Secondary	Dietary intake		Baseline, 3 months and 6 months	No
Secondary	Physical activity		Baseline, 3 months and 6 months	No
Secondary	Cognitive performance		Baseline and 6 months	No
Secondary	Blood pressure		Baseline, 3 months and 6 months	No