NCT01640145

Brief Summary

Maintenance of skeletal muscle mass is crucial during lifespan to retain health and functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known phenomenon in the elderly and a major challenge viewed from an individual, and a socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be markedly affected by physical activity and nutritional interventions even at old age. Recently, a study in young individuals showed that an acute bout of easily tolerated low intensity exercise can prolong the muscle building effects of a milk protein intake compared to a non-exercised situation. Therefore, the major aim of the present project is to evaluate, whether a low intensity exercise regime in conjunction with milk protein supplementation can induce positive adaptations on parameters related to muscle size and function in elderly. The study focuses on the acute muscle protein synthesis response to low intensity exercise and protein supplementation measured with stable isotope tracer techniques. It is hypothesized that light muscle activity can augment and prolong the effects of protein feeding. If a light resistance exercise protocol as investigated in the present project can prove beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge sarcopenia in a new and tolerable way.

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 Jul 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

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

July 9, 2012

Last Update Submit

January 5, 2015

Conditions

Skeletal Muscle Protein Synthesis in ElderlyProtein KineticsSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle protein synthesis

    Measured as myofibrillar fractional synthetic rate (%/hour) in three periods pre intervention: 0-3 hours, 3-7 hours and 7-10 hours

    6 months

Secondary Outcomes (3)

  • Gene expression

    1.5 years

  • Intracellular signaling

    1.5 years

  • Amino acid transporter

    2 years

Study Arms (3)

Carbohydrate

PLACEBO COMPARATOR
Other: Exercise

Protein continous boluses

ACTIVE COMPARATOR
Dietary Supplement: ProteinOther: Exercise

Protein 2 boluses

ACTIVE COMPARATOR
Dietary Supplement: ProteinOther: Exercise

Interventions

ProteinDIETARY_SUPPLEMENT

Whey protein intake

Protein 2 bolusesProtein continous boluses
ExerciseOTHER

Unilateral low intensity exercise

CarbohydrateProtein 2 bolusesProtein continous boluses

Eligibility Criteria

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

You may qualify if:

  • Male
  • \>65 year old
  • Healthy
  • BMI \<28

You may not qualify if:

  • Smoker
  • Type II diabetic
  • Intake of medicine or supplements which will affect skeletal muscle protein synthesis
  • Alcohol intake \>21 units/week.
  • Frequent exercise or hard physical labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

ProteinsExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD Student

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 13, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

October 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01

Locations

DK(1)