search
Back to results

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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Protein drink
Placebo drink
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, frail elderly, protein drink, skeletal muscle mass, muscle mass in elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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)
  • Renal insufficiency (eGFR <60 mL/min/1.73 m2)
  • Allergic or sensitive for milk proteins

Sites / Locations

  • Wageningen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein drink

Placebo drink

Arm Description

Outcomes

Primary Outcome Measures

Change in skeletal muscle mass

Secondary Outcome Measures

Physical performance
Blood parameters related to the outcome measures
Dietary intake
Physical activity
Cognitive performance
Blood pressure

Full Information

First Posted
February 12, 2010
Last Updated
January 30, 2012
Sponsor
Wageningen University
Collaborators
Maastricht University Medical Center, Top Institute Food and Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT01109628
Brief Title
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
Acronym
ProMuscle
Official Title
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University
Collaborators
Maastricht University Medical Center, Top Institute Food and Nutrition

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, frail elderly, protein drink, skeletal muscle mass, muscle mass in elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein drink
Arm Type
Experimental
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein drink
Intervention Description
Twice a day during 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Twice a day during 6 months
Primary Outcome Measure Information:
Title
Change in skeletal muscle mass
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Physical performance
Time Frame
Baseline, 3 months and 6 months
Title
Blood parameters related to the outcome measures
Time Frame
Baseline, 3 months and 6 months
Title
Dietary intake
Time Frame
Baseline, 3 months and 6 months
Title
Physical activity
Time Frame
Baseline, 3 months and 6 months
Title
Cognitive performance
Time Frame
Baseline and 6 months
Title
Blood pressure
Time Frame
Baseline, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6703HD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24374288
Citation
van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
Results Reference
derived
PubMed Identifier
24045855
Citation
van der Zwaluw NL, van de Rest O, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. The impact of protein supplementation on cognitive performance in frail elderly. Eur J Nutr. 2014 Apr;53(3):803-12. doi: 10.1007/s00394-013-0584-9. Epub 2013 Sep 18.
Results Reference
derived
PubMed Identifier
22889730
Citation
Tieland M, van de Rest O, Dirks ML, van der Zwaluw N, Mensink M, van Loon LJ, de Groot LC. Protein supplementation improves physical performance in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):720-6. doi: 10.1016/j.jamda.2012.07.005. Epub 2012 Aug 11.
Results Reference
derived

Learn more about this trial

Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

We'll reach out to this number within 24 hrs