NCT00929929

Brief Summary

The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 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

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

June 29, 2009

Last Update Submit

October 8, 2014

Conditions

Ageing

Keywords

AgingFunctionalitySarcopeniaLeucineProgressive resistance exercise

Outcome Measures

Primary Outcomes (1)

  • Muscle strength.

    Baseline, 4 weeks, 12 weeks

Secondary Outcomes (1)

  • Functionality

    Baseline, 4 weeks, 12 weeks

Other Outcomes (1)

  • Quality of life

    Baseline, 4 weeks, 12 weeks

Study Arms (2)

L-Leucine

EXPERIMENTAL

This arm receives a supplement of leucine along with a progressive resistance exercise program.

Dietary Supplement: L-leucine.Behavioral: Exercise program.

Maltodextrin

PLACEBO COMPARATOR

This arm receives a supplement of maltodextrin along with a progressive resistance exercise program.

Dietary Supplement: Maltodextrin.Behavioral: Exercise program.

Interventions

L-leucine.DIETARY_SUPPLEMENT

10 g of leucine per day, during 12 weeks.

Also known as: Leucine.
L-Leucine
Maltodextrin.DIETARY_SUPPLEMENT

10 g of maltodextrin per day, during 12 weeks.

Also known as: Maxijul.
Maltodextrin
Exercise program.BEHAVIORAL

Progressive resistance exercise program 4 days a week, during 12 weeks.

Also known as: Resistance exercise.
L-LeucineMaltodextrin

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Over 70 years of age.
  • Subjects capable of doing resistance exercise.

You may not qualify if:

  • Hospitalized patients.
  • Disabled patients (i.e., not being able to exercise).
  • Patients that usually train in resistance exercise.
  • Patients with chronic renal failure.
  • Patients with a fractured extremity during the last 6 months.
  • Patients that follow diets with a protein restriction.
  • Patients with oral nutritional support, enteral or parenteral nutrition.
  • Patients in a low calorie diet to lose weight.
  • Patients using pharmacological treatment with anorexigenic effects, anabolic steroids or corticosteroids.
  • Patients with cognitive impairment or major psychiatric disorder.
  • Non-signed informed consent.
  • Any patient not capable to properly follow the treatment or not considered adequate by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Dietetics Unit, Hospital Clínic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND

Related Links

MeSH Terms

Conditions

Sarcopenia

Interventions

LeucinemaltodextrinResistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria T Forga, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Joan Trabal, RD, MS

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Pere Leyes, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Andreu Farran, PhD

    University of Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

ES(1)