Skeletal Muscle Protein Synthesis in ElderlyNCT01640145
Effect of Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly
A study testing Protein and Exercise in people with Skeletal Muscle Protein Synthesis in Elderly and Protein Kinetics, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Protein Synthesis in Elderly, Protein Kinetics, Sarcopenia
- What is being tested?
- Protein and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- >65 year old
- Healthy
- BMI <28
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen
Copenhagen, Copenhagen, DK-2400
About this study
Official title: 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.
- Being tested
- Protein, Exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Whey protein intake
ExerciseOther
Unilateral low intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate | Placebo comparator | Not described Receives: Other: Exercise |
| Protein continous boluses | Active comparator | Not described Receives: Dietary Supplement: Protein; Other: Exercise |
| Protein 2 boluses | Active comparator | Not described Receives: Dietary Supplement: Protein; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 1.5 years
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.
Measured: 1.5 years
Amino acid transporter
Through Western Blotting and RT-PCR protein and mRNA expression of amino acid transporters (LAT1, SNAT2, PAT1) are analyzed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Protein Synthesis in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640145
- Sponsor's protocol ID
- BBH98
- Status last verified
- Jan 2015
- First submitted
- 9 Jul 2012
- Last updated
- 6 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01640145
- Acronym / sponsor ID
- BBH98
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Placebo comparator | Other: Exercise |
| Protein continous boluses | Active comparator | Dietary Supplement: Protein, Other: Exercise |
| Protein 2 boluses | Active comparator | Dietary Supplement: Protein, Other: Exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male
- >65 year old
- Healthy
- BMI <28
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinWhey protein intake | Dietary supplement | Protein 2 boluses, Protein continous boluses |
| ExerciseUnilateral low intensity exercise | Other | Carbohydrate, Protein 2 boluses, Protein continous boluses |
Primary outcome
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
3 secondary outcomes
Gene expression
Time frame: 1.5 years
Intracellular signaling
Time frame: 1.5 years
Amino acid transporter
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and Exercise in people with Skeletal Muscle Protein Synthesis in Elderly and Protein Kinetics, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle protein synthesis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.