NCT00807508

Brief Summary

In the present study the investigators aim to determine whether leucine supplementation can augment muscle mass and strength and improve body composition in healthy elderly men

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
Last Updated

December 12, 2008

Status Verified

December 1, 2008

Enrollment Period

11 months

First QC Date

December 11, 2008

Last Update Submit

December 11, 2008

Conditions

SarcopeniaAtrophyAging

Outcome Measures

Primary Outcomes (1)

  • muscle mass and body composition

    before and after 12 wk intervention

Secondary Outcomes (1)

  • muscle strength

    before and after 12 wk intervention

Study Arms (2)

1

EXPERIMENTAL

daily leucine supplementation

Dietary Supplement: leucine

2

PLACEBO COMPARATOR

daily placebo supplementation

Dietary Supplement: placebo

Interventions

placeboDIETARY_SUPPLEMENT

wheat meal capsules with each main meal

2
leucineDIETARY_SUPPLEMENT

daily leucine capsules with each main meal

1

Eligibility Criteria

Age65 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • living independently

You may not qualify if:

  • Diabetes cardiovascular disease orthopedic limitations history of resistance training in past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6200 MD, Netherlands

Location

Related Publications (1)

  • Verhoeven S, Vanschoonbeek K, Verdijk LB, Koopman R, Wodzig WK, Dendale P, van Loon LJ. Long-term leucine supplementation does not increase muscle mass or strength in healthy elderly men. Am J Clin Nutr. 2009 May;89(5):1468-75. doi: 10.3945/ajcn.2008.26668. Epub 2009 Mar 25.

    PMID: 19321567DERIVED

MeSH Terms

Conditions

SarcopeniaAtrophy

Interventions

Leucine

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

December 12, 2008

Record last verified: 2008-12

Locations

NL(1)