CClinicalTrials.gg
Sign In
CompletedNCT01110369ProMuscleUpdated Apr 4, 2025

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

An interventional study of Protein drink and Resistance exercise training in Sarcopenia, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Wageningen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Sarcopenia

Browse trials for

Keywords

  • sarcopenia
  • frail elderly
  • protein drink
  • resistance exercise
  • Skeletal muscle mass
  • muscle mass in elderly
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Frail elderly individuals
  • Able to understand and perform the study procedures

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Resistance exercise training and protein drink

    Dietary Supplement: Protein drink · Other: Resistance exercise training

  • Placebo comparator
    Resistance exercise training and placebo drink

    Other: Resistance exercise training · Dietary Supplement: Placebo drink

Interventions

  • Dietary supplementProtein drink

    Protein drink twice a day during 6 months.

  • OtherResistance exercise training

    Resistance exercise training twice per week during 6 months.

  • Dietary supplementPlacebo drink

    Placebo drink twice a day during 6 months.

06

What researchers measure

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

07

Study locations

1 site
  • Wageningen University
    Wageningen, Gelderland 6703HD, Netherlands
08

References and documents

Publications

  • Dorhout BG, de Groot LCPGM, van Dongen EJI, Doets EL, Haveman-Nies A. Effects and contextual factors of a diet and resistance exercise intervention vary across settings: an overview of three successive ProMuscle interventions. BMC Geriatr. 2022 Mar 9;22(1):189. doi: 10.1186/s12877-021-02733-6. PubMed 35264105 ↗
  • 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. PubMed 24374288 ↗
  • Tieland M, Dirks ML, van der Zwaluw N, Verdijk LB, van de Rest O, de Groot LC, van Loon LJ. Protein supplementation increases muscle mass gain during prolonged resistance-type exercise training in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):713-9. doi: 10.1016/j.jamda.2012.05.020. Epub 2012 Jul 6. PubMed 22770932 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01110369
Lead sponsor
Wageningen University
Collaborators
Top Institute Food and Nutrition, Maastricht University Medical Center
Responsible party
Lisette de Groot (Professor, Wageningen University) — Principal investigator
First posted
Apr 26, 2010
Start date
Nov 2009
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Apr 4, 2025

Study contacts

Lisette de Groot, Professor
principal investigator · Wageningen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Sarcopenia→

Other studies from this sponsor

Wageningen University

Start the discussion