Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People (ProMuscle)

January 30, 2012 updated by: Lisette de Groot, Wageningen University
The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6703HD
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo drink
Dietary supplement: Placebo drink
Twice a day during 6 months
Experimental: Protein drink
Dietary supplement: Protein drink
Twice a day during 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in skeletal muscle mass
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical performance
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Blood parameters related to the outcome measures
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Dietary intake
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Physical activity
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months
Cognitive performance
Time Frame: Baseline and 6 months
Baseline and 6 months
Blood pressure
Time Frame: Baseline, 3 months and 6 months
Baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Maastricht University Medical Center
Top Institute Food and Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1002-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on Protein drink

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe