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

NCT ID: NCT01110369

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Resistance exercise training and protein drink

Group Type EXPERIMENTAL

Protein drink

Intervention Type DIETARY_SUPPLEMENT

Protein drink twice a day during 6 months.

Resistance exercise training

Intervention Type OTHER

Resistance exercise training twice per week during 6 months.

Resistance exercise training and placebo drink

Group Type PLACEBO_COMPARATOR

Resistance exercise training

Intervention Type OTHER

Resistance exercise training twice per week during 6 months.

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Placebo drink twice a day during 6 months.

Interventions

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Protein drink

Protein drink twice a day during 6 months.

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise training

Resistance exercise training twice per week during 6 months.

Intervention Type OTHER

Placebo drink

Placebo drink twice a day during 6 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Lisette de Groot

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisette de Groot, Professor

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 35264105 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24374288 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22770932 (View on PubMed)

Other Identifiers

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A1002-2

Identifier Type: -

Identifier Source: org_study_id

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