NCT01110369

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

February 12, 2010

Last Update Submit

April 1, 2025

Conditions

Sarcopenia

Keywords

sarcopeniafrail elderlyprotein drinkresistance exerciseSkeletal muscle massmuscle mass in elderly

Outcome Measures

Primary Outcomes (1)

  • Change in skeletal muscle mass

    Baseline, 3 months and 6 months

Secondary Outcomes (6)

  • Physical performance

    Baseline, 3 months and 6 months

  • Blood will be collected to assess parameters related to the outcome measures

    Baseline, 3 months and 6 months

  • Dietary intake

    Baseline, 3 months and 6 months

  • Physical activity

    Baseline, 3 months and 6 months

  • Cognitive performance

    Baseline and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Resistance exercise training and protein drink

EXPERIMENTAL
Dietary Supplement: Protein drinkOther: Resistance exercise training

Resistance exercise training and placebo drink

PLACEBO COMPARATOR
Other: Resistance exercise trainingDietary Supplement: Placebo drink

Interventions

Protein drinkDIETARY_SUPPLEMENT

Protein drink twice a day during 6 months.

Resistance exercise training and protein drink
Resistance exercise trainingOTHER

Resistance exercise training twice per week during 6 months.

Resistance exercise training and placebo drinkResistance exercise training and protein drink
Placebo drinkDIETARY_SUPPLEMENT

Placebo drink twice a day during 6 months.

Resistance exercise training and placebo drink

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 35264105DERIVED

  • 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.

    PMID: 24374288DERIVED

  • 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.

    PMID: 22770932DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lisette de Groot, Professor

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2010

First Posted

April 26, 2010

Study Start

November 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations

NL(1)