Clinical trial NCT01110369: A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People
Official title: A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
frail elderly
protein drink
resistance exercise
Skeletal muscle mass
muscle mass in elderly
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
name: Maastricht University Medical Center
First posted: 2010-04-26
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)
* Presence of coronary heart disease (ECG)
* Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Allergic or sensitive for milk proteins

Primary outcomes:
measure: Change in skeletal muscle mass
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Physical performance
timeFrame: Baseline, 3 months and 6 months
measure: Blood will be collected to assess parameters related to the outcome measures
timeFrame: Baseline, 3 months and 6 months
measure: Dietary intake
timeFrame: Baseline, 3 months and 6 months
measure: Physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Cognitive performance
timeFrame: Baseline and 6 months
measure: Blood pressure
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Wageningen University
name: Lisette de Groot, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.