Casein+ study: Dietary strategies to augment post-prandial muscle protein accretion

ISRCTN ISRCTN17091496
DOI https://doi.org/10.1186/ISRCTN17091496
Secondary identifying numbers MEC 10-3-080
Submission date
14/09/2012
Registration date
10/10/2012
Last edited
16/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Luc van Loon
Scientific

Universiteit Maastricht
PO box 616
Maastricht
6200 MD
Netherlands

Email l.vanloon@maastrichtuniversity.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDietary strategies to augment post-prandial muscle protein accretion: a randomised controlled trial
Study objectives1. 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(s)Medical Ethics Committee, Maastricht University, 13/12/2010, ref: NL34355.068.10 / MEC 10-3-080
Health condition(s) or problem(s) studiedSarcopenia
Intervention1. 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 typeOther
Primary outcome measure1. Muscle protein synthesis rate
2. Muscle biopsy at t=0 (before drink), t=120 and t=360 min
Secondary outcome measuresPlasma 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 study start date01/01/2011
Completion date15/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexMale
Target number of participants48
Key inclusion criteria1. Males
2. Age 70-85 years or age 18-30 years
3. Body mass index (BMI) < 30 kg∙m^2
Key exclusion criteria1. 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
Date of first enrolment01/01/2011
Date of final enrolment15/09/2012

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Universiteit Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

Maastricht University (Netherlands)
University/education

PO Box 616
Maastricht
6200 MD
Netherlands

Email l.vanloon@maastrichtuniversity.nl
Website http://www.maastrichtuniversity.nl/
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

University/education

Maastricht University (Netherlands)
Private sector organisation / Universities (academic only)
Alternative name(s)
Maastricht University, UM
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

16/06/2017: Plain English summary added.