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OpenTrials
Completed

NCT Number: NCT01110369

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

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

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein drink

Dietary Supplement

Protein drink twice a day during 6 months.

Resistance Exercise Training

Other

Resistance exercise training twice per week during 6 months.

Placebo drink

Dietary Supplement

Placebo drink twice a day during 6 months.

Primary outcomes

  1. Change in skeletal muscle mass

    Time frame: Baseline, 3 months and 6 months

Secondary outcomes

  1. Physical performance

    Time frame: Baseline, 3 months and 6 months

  2. Blood will be collected to assess parameters related to the outcome measures

    Time frame: Baseline, 3 months and 6 months

  3. Dietary intake

    Time frame: Baseline, 3 months and 6 months

  4. Physical activity

    Time frame: Baseline, 3 months and 6 months

  5. Cognitive performance

    Time frame: Baseline and 6 months

  6. Blood pressure

    Time frame: Baseline, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Maastricht University Medical Center
  • Top Institute Food and Nutrition

Registry information

Acronym: ProMuscle

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 26, 2010
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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