NCT01317511

Brief Summary

Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

6 months

First QC Date

March 16, 2011

Last Update Submit

March 16, 2011

Conditions

Muscle Synthesis

Outcome Measures

Primary Outcomes (1)

  • Protein synthesis

    Overnight protein synthesis

    overnight (12 h)

Study Arms (2)

Protein

EXPERIMENTAL

Protein drink

Dietary Supplement: Protein

Placebo

PLACEBO COMPARATOR

water

Dietary Supplement: Protein

Interventions

ProteinDIETARY_SUPPLEMENT

Protein drink

Also known as: casein vs water
PlaceboProtein

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Males
  • Age between 65 and 80 years
  • BMI \< 30 kg/m2

You may not qualify if:

  • Type 2 diabetic patients
  • Use of medication
  • All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • Use of anticoagulants, blood diseases, allergy for lidocain.
  • Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
  • Patients suffering from PKU (Phenylketonuria).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.

    PMID: 32069356DERIVED

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Luc van Loon, Prof.

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

NL(1)