NCT01883674

Brief Summary

This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:

  • Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
  • Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
  • Examine the impact of exercise and proteins on liver enzymes;
  • Examine the impact of exercise and proteins on a hormone that controls hunger;
  • Evaluate the program's impact on the ability of the body to produce energy. All participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training:
  • Milk proteins (from milk beverage)
  • Essential amino acids (added to a soya beverage)
  • No protein (rice beverage - control group) Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins and EAA will be both superior to control group. This would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

February 7, 2013

Last Update Submit

December 1, 2014

Conditions

Keywords

SarcopeniaPhysical capacityMuscle forceMuscle qualityMilk proteinsEssential amino acidsProteinsResistance trainingExercise

Outcome Measures

Primary Outcomes (1)

  • Muscle mass

    At baseline and post intervention (17th week)

Secondary Outcomes (6)

  • Relative strength

    At baseline and post intervention (17th week)

  • Blood markers of inflammation

    At baseline and post intervention (17th week)

  • Plasma Lipid profile

    At baseline and post intervention (17th week)

  • Plasma creatinine

    At baseline, mid (8th week) and post intervention (17th week)

  • Blood markers of fatty liver

    At baseline and post intervention (17th week)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Dietary intakes

    At baseline, mid (8th week) and post intervention (17th week)

  • Physical activity level

    At baseline and post intervention (17th week)

Study Arms (3)

Milk proteins

EXPERIMENTAL

This group will do a resistance training + milk proteins (milk beverage)

Other: Resistance training

Essential amino acids (add to soya bvg)

EXPERIMENTAL

This group will do a resistance training + essential amino acids (added to soya beverage)

Other: Resistance training

No protein (control)

PLACEBO COMPARATOR

This group will do a resistance training + ingestion of the control beverage (no protein, rice beverage)

Other: Resistance training

Interventions

All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.

Essential amino acids (add to soya bvg)Milk proteinsNo protein (control)

Eligibility Criteria

Age65 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years
  • francophone or understanding French
  • muscle mass index \< 10.75 kg/m2 (Janssen et al, 2004)
  • body mass index \<30kg/m²
  • weight stable (\< 2 kg) for 6 mo
  • no resistance exercise for 3 years
  • controlled blood pressure for at least 6 months

You may not qualify if:

  • major physical disability
  • medical treatment influencing metabolism
  • statin treatment
  • diagnosis or any sign of kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Isabelle J. Dionne, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

June 21, 2013

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

December 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations