Plain English Summary
Background and study aims
It is thought that the production of muscle protein after a meal in response to consuming protein and/or amino acids is impaired in the elderly compared to the young. Also, consuming carbohydrates at the same time increases secretion of the hormone insulin and increases muscle protein production in the young. However, it is unclear how the elderly respond to the combined intake of protein and carbohydrates. Likewise, consuming the amino acid leucine may also increase muscle protein production. Adding carbohydrate or leucine to protein may represent effective strategies to overcome the impaired muscle protein production in the elderly. This study consists of three substudies. The aim of the first study is to determine if the response to combined protein and carbohydrate intake is different between young and elderly men. The aim of the second study is to investigate whether consuming carbohydrate as well increases muscle protein production in elderly men. The aim of the third study is to examine whether consuming leucine increases muscle protein production in elderly men.
Who can participate?
Healthy male volunteers aged 18-30 and 70-85
What does the study involve?
Participants are randomly allocated to consume a drink containing either protein alone or protein in combination with carbohydrate or leucine. Blood samples and muscle biopsies (tissue samples) are collected to measure muscle protein production.
What are the possible benefits and risks of participating?
There are no benefits for participating in the study. There are minimal risks involved in participating in this study. The collection of blood samples is comparable to a normal blood draw and the only risk is a small local hematoma (a solid swelling of clotted blood). This is the same for the muscle biopsies. The cut made for taking the muscle biopsy is done by an experienced physician, following local anesthetics of the skin and muscle, and will heal completely. The test drinks contain dietary protein which is safe for human consumption.
Where is the study run from?
Maastricht University Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
January 2011 to September 2012
Who is funding the study?
Maastricht University Medical Centre (Netherlands)
Who is the main contact?
Prof. Luc van Loon
l.vanloon@maastrichtuniversity.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Luc van Loon
ORCID ID
Contact details
Universiteit Maastricht
PO box 616
Maastricht
6200 MD
Netherlands
-
l.vanloon@maastrichtuniversity.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 10-3-080
Study information
Scientific title
Dietary strategies to augment post-prandial muscle protein accretion: a randomised controlled trial
Acronym
Study hypothesis
1. The postprandial muscle protein synthetic response to the co-ingestion of protein and carbohydrates is attenuated in elderly when compared with the young.
2. The combined intake of protein and carbohydrates augments postprandial muscle protein synthesis in elderly men when compared with protein intake alone.
3. The combined intake of protein and leucine augments postprandial muscle protein synthesis in elderly men when compared with protein intake alone.
Ethics approval
Medical Ethics Committee, Maastricht University, 13/12/2010, ref: NL34355.068.10 / MEC 10-3-080
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Sarcopenia
Intervention
1. 20 g intrinsically labeled casein protein only in healthy elderly men
2. 20 g intrinsically labeled casein protein with 40 g of carbohydrate in healthy elderly men
3. 20 g intrinsically labeled casein protein with 2.5 g of leucine in healthy elderly men
4. 20 g intrinsically labeled casein protein with 40 g of carbohydrate in healthy young men
It was an acute intervention study thus a drink containing the above mentioned ingredients was only provided followed by the described measurements (multiple blood draws and three muscle biopsies)
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Muscle protein synthesis rate
2. Muscle biopsy at t=0 (before drink), t=120 and t=360 min
Secondary outcome measures
Plasma glucose, insulin, and amino acid concentrations. Blood draws at t=0 (before drink), 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Overall trial start date
01/01/2011
Overall trial end date
15/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males
2. Age 70-85 years or age 18-30 years
3. Body mass index (BMI) < 30 kg∙m^2
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
48
Participant exclusion criteria
1. Type II diabetes
2. All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis)
3. Use of anticoagulants, blood diseases, allergy for lidocain
4. Use of Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid
5. Patients suffering from Phenylketonuria (PKU)
6. Participation in any regular exercise program
Recruitment start date
01/01/2011
Recruitment end date
15/09/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteit Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Maastricht University (Netherlands)
Sponsor details
PO Box 616
Maastricht
6200 MD
Netherlands
-
l.vanloon@maastrichtuniversity.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Maastricht University (Netherlands)
Alternative name(s)
Maastricht University, UM
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary