NCT01820975

Brief Summary

In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

March 18, 2013

Last Update Submit

March 21, 2017

Conditions

Keywords

Muscle protein synthesisDietary protein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein fractional synthetic rate following protein ingestion

    The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.

    3 hours

Study Arms (2)

High protein intake

EXPERIMENTAL

High protein intake: large bolus of protein in teh diet the day before testing

Dietary Supplement: High protein intake

No protein intake

PLACEBO COMPARATOR

No protein in the diet the day before testing

Other: Placebo comparator

Interventions

High protein intakeDIETARY_SUPPLEMENT
High protein intake

No protein intake

Also known as: control group
No protein intake

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Aged between 18-35 years
  • Healthy, recreationally active
  • BMI \< 30 kg/m2

You may not qualify if:

  • Smoking
  • Allergies to milk proteins (whey or casein)
  • Vegetarians
  • Diagnosed GI tract diseases
  • Female
  • Arthritic conditions
  • A history of neuromuscular problems
  • Previous participation in amino acid tracer studies
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

Sarcopenia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 29, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

February 1, 2017

Last Updated

March 22, 2017

Record last verified: 2015-05