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

Wageningen University

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Placebo drink; Other: Resistance exercise training; Dietary Supplement: Protein drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01110369

A1002-2

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Resistance exercise training and protein drink

Experimental group

Treatment:

Dietary Supplement: Protein drink

Other: Resistance exercise training

Resistance exercise training and placebo drink

Placebo Comparator group

Treatment:

Other: Resistance exercise training

Dietary Supplement: Placebo drink