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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01640145
Other study ID # BBH98
Secondary ID
Status Completed
Phase N/A
First received July 9, 2012
Last updated January 5, 2015
Start date July 2012
Est. completion date October 2014

Study information

Verified date January 2015
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2014
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Protein
Whey protein intake
Other:
Exercise
Unilateral low intensity exercise

Locations

Country Name City State
Denmark Institute of Sports Medicine Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Gene expression 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 No
Secondary Intracellular signaling 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 No
Secondary Amino acid transporter Through Western Blotting and RT-PCR protein and mRNA expression of amino acid transporters (LAT1, SNAT2, PAT1) are analyzed 2 years No
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