Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

NCT01109628 | Completed

• 1 other identifier: A1002-1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcopenia

Keywords

sarcopenia; frail elderly; protein drink; skeletal muscle mass; muscle 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 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

Study Arms (2)

Protein drink

EXPERIMENTAL

Dietary Supplement: Protein drink

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Interventions

Protein drink DIETARY_SUPPLEMENT

Twice a day during 6 months

Protein drink

Placebo drink DIETARY_SUPPLEMENT

Twice a day during 6 months

Placebo drink

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older 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)
• Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
• Allergic or sensitive for milk proteins

Sponsors & Collaborators

• Wageningen University: lead
• Maastricht University Medical Center: collaborator
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Location

Related Publications (3)

• 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: 24374288 DERIVED

• 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.

  PMID: 24045855 DERIVED

• 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.

  PMID: 22889730 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

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 23, 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)