NCT01239277

Brief Summary

Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether combined nutrient intake plays an important role in stimulation of the muscle protein growth in elderly people; and whether it represent effective strategies to overcome the impaired muscle protein synthesis in elderly when compared with young subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
6 months 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

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

November 10, 2010

Last Update Submit

September 13, 2011

Conditions

Aging

Keywords

muscleFSRproteincarbohydrateleucine

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    Muscle protein synthesis will be expressed as fractional synthetic rate (FSR) by dividing the increment in enrichment in the product, i.e. protein-bound C13phe, by the enrichment of the precursor (=plasma availability).

    6 h postprandial period

Study Arms (4)

protein (elderly)

EXPERIMENTAL
Other: protein

protein and carbohydrate (elderly)

EXPERIMENTAL
Other: protein and carbohydrate

protein and carbohydrate (young)

EXPERIMENTAL
Other: protein and carbohydrate

protein and leucine (elderly)

EXPERIMENTAL
Other: protein and leucine

Interventions

proteinOTHER

20g protein

protein (elderly)
protein and carbohydrateOTHER

20g protein and 20g carbohydrate

protein and carbohydrate (elderly)protein and carbohydrate (young)
protein and leucineOTHER

20g protein, 2.5g leucine

protein and leucine (elderly)

Eligibility Criteria

Age70 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • males
  • years or 18-30 years
  • BMI \< 30

You may not qualify if:

  • Type II diabetes
  • All co morbidities interacting with mobility and muscle metabolism of the lower limbs
  • Use of anticoagulants
  • Patients suffering from Phenylketonuria
  • Participation in any regular exercise programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiteit Maastricht, Bewegingswetenschappen

Maastricht, Limburg, Netherlands

Location

Related Links

MeSH Terms

Interventions

ProteinsCarbohydratesLeucine

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsAmino Acids, Branched-ChainAmino AcidsAmino Acids, Essential

Study Officials

  • A. de Lange

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

NL(1)