- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01640145
Effect of Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly
Impact of Acute Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly: a Randomized Controlled Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, DK-2400
- Institute of Sports Medicine Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- >65 year old
- Healthy
- BMI <28
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Carbohydrate
|
Unilateral low intensity exercise
|
Active Comparator: Protein continous boluses
|
Unilateral low intensity exercise
Whey protein intake
|
Active Comparator: Protein 2 boluses
|
Unilateral low intensity exercise
Whey protein intake
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle protein synthesis
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression
Time Frame: 1.5 years
|
Through real time RT-PCR we measure the fold changes in gene expression of targets involved in skeletal muscle remodeling: myogenic factors, atrogenes, matrix related genes
|
1.5 years
|
Intracellular signaling
Time Frame: 1.5 years
|
Through Western Blotting we will measure changes in intracellular hypertrophy signaling.
That is the activity of protein targets from the Akt-mTORC1 and Akt-FOXO pathways.
|
1.5 years
|
Amino acid transporter
Time Frame: 2 years
|
Through Western Blotting and RT-PCR protein and mRNA expression of amino acid transporters (LAT1, SNAT2, PAT1) are analyzed
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBH98
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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