Condition category
Musculoskeletal Diseases
Date applied
14/09/2012
Date assigned
10/10/2012
Last edited
10/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 December 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 below 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

Drug

Phase

Not Applicable

Drug names

Casein, leucine

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

http://www.maastrichtuniversity.nl/

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

Publication citations

Additional files

Editorial Notes