NCT00557388

Brief Summary

Aging is associated with the loss of lean muscle mass, termed sarcopenia. Food intake and in particular the ingestion of protein or amino acids has been shown to be a powerful stimulus to promote net muscle protein anabolism. However this anabolic response following a meal-like protein bolus seems to be blunted in the elderly as compared to young adults. The first aim of this proposal is to investigate the post-prandial muscle protein synthesis rates in young and elderly men in response to a meal-like protein bolus after a period of rest or physical activity (study A). The rest trial (REST) will act as a proof-of-principle study to examine the blunted protein synthetic response in the elderly, and as a control trial in comparison with the exercise trial (EXC) to establish the surplus value of physical activity prior to protein intake on muscle protein synthesis. The second aim of this proposal is to determine the surplus value of an increased quantity of the ingested protein bolus (study B). Large amounts of protein (40 and 60 g) will be compared to a meal-like amount of protein (20 g) as a means to maximize plasma amino acid availability and/or to stimulate muscle protein anabolism. The third aim of this proposal is to study the differences in quality of the ingested protein bolus (study C). Instead of significantly increasing the quantity of the protein bolus, we will also apply a more practical approach to augment skeletal muscle protein synthesis rates; modifying the digestibility or amino acid composition of a meal-like protein bolus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

2.9 years

First QC Date

November 13, 2007

Last Update Submit

September 13, 2011

Conditions

Keywords

muscle lossagingproteinamino acidsexerciseprotein synthesis

Outcome Measures

Primary Outcomes (1)

  • All interventions will affect muscle protein synthesis. With the application of amino acid tracer methodology we are able to determine muscle protein synthesis.

    6 hours

Secondary Outcomes (1)

  • Differences in rate of uptake/absorption from the intestine.

    6 hours

Study Arms (10)

1

EXPERIMENTAL

Young men 18-30 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino AcidsOther: Physical exercise

2

EXPERIMENTAL

Young men 18-30 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

3

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino AcidsOther: Physical exercise

4

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

5

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

6

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

7

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

8

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

9

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

10

EXPERIMENTAL

Old men 70-85 years, BMI \< 27 kg/m2

Dietary Supplement: Protein/Amino Acids

Interventions

Protein/Amino AcidsDIETARY_SUPPLEMENT

Casein Whey Leucine

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The physical exercise protocol will consist of low intensity cycling and light resistance-type exercise; after 5 minutes of self-paced cycling, subjects will perform 6 sets of 10 repetitions on the horizontal leg press machine (Technogym BV, Rotterdam, The Netherlands) and 6 sets of 10 repetitions on the leg extension machine (Technogym BV, Rotterdam, The Netherlands). The first 2 sets of both resistance exercises will be performed at 40% of the subjects' 1RM. Sets 3-4, and 5-6 will be performed at 55% and 75% of 1RM, respectively, with 2 minutes rest intervals between sets.

13

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In study A, non-obese male subjects (BMI \<27) between the age of 18-30 yrs and 70-85 yrs will be selected.
  • In studies B and C, non-obese male subjects (BMI \<27) between the age of 70-85 yrs will be selected.

You may not qualify if:

  • Type II diabetes or other known diseases
  • Use of medication
  • Female
  • Other ages or BMI than indicated above
  • Participation in any regular exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maastricht

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (4)

  • Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

  • Pennings B, Groen B, de Lange A, Gijsen AP, Zorenc AH, Senden JM, van Loon LJ. Amino acid absorption and subsequent muscle protein accretion following graded intakes of whey protein in elderly men. Am J Physiol Endocrinol Metab. 2012 Apr 15;302(8):E992-9. doi: 10.1152/ajpendo.00517.2011. Epub 2012 Feb 14.

  • Pennings B, Boirie Y, Senden JM, Gijsen AP, Kuipers H, van Loon LJ. Whey protein stimulates postprandial muscle protein accretion more effectively than do casein and casein hydrolysate in older men. Am J Clin Nutr. 2011 May;93(5):997-1005. doi: 10.3945/ajcn.110.008102. Epub 2011 Mar 2.

  • Pennings B, Koopman R, Beelen M, Senden JM, Saris WH, van Loon LJ. Exercising before protein intake allows for greater use of dietary protein-derived amino acids for de novo muscle protein synthesis in both young and elderly men. Am J Clin Nutr. 2011 Feb;93(2):322-31. doi: 10.3945/ajcn.2010.29649. Epub 2010 Nov 17.

MeSH Terms

Conditions

SarcopeniaMuscular AtrophyMotor Activity

Interventions

ProteinsAmino AcidsExercise

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luc van Loon, Phd

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations