NCT01986842

Brief Summary

Protein intake stimulates muscle protein synthesis. From the standpoint of maintaining skeletal muscle mass with aging, it is important to optimize the adaptive response to food intake. However, a paucity of information is available describing the effects of habitual dietary protein intake (i.e. either high or low amounts of dietary protein consumed on a regular basis), on the subsequent meal-induced stimulation of muscle protein synthesis. An adaptation to a diet of several days or weeks may involve splanchnic and/or skeletal muscle adaptations that may further enhance, or decrease, the amino acid sensitivity of muscle protein synthesis after protein ingestion. The aim of this study is to investigate the effect of a habitual (14 days) high protein diet when compared with low protein diet on digestion and absorption kinetics and the subsequent muscle protein synthetic response to dietary protein ingestion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

First Submitted

Initial submission to the registry

November 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

November 12, 2013

Last Update Submit

November 27, 2014

Conditions

Sarcopenia

Keywords

Muscle protein synthesisDigestion and absorption kineticsLeucineWhey protein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis rates

    Change in MPS rates during the postprandial phase when compared with the basal phase

    0-5 h postprandial period

Secondary Outcomes (1)

  • Digestion/Absorption kinetics

    0-5 h postprandial period

Other Outcomes (3)

  • Plasma insulin

    0-5 h postprandial period

  • Plasma amino acid concentrations

    0-5 h postprandial period

  • Whole-body protein metabolism

    0-5 h postprandial period

Study Arms (2)

Low protein

EXPERIMENTAL

Subject will receive a low protein diet (0.7 g/kg BW/day) for 14 days prior to the experimental trial

Dietary Supplement: Protein diet

High protein

EXPERIMENTAL

Subjects will receive a high protein diet (1.5 g/kg BW/day) for 14 days prior to the experimental trial

Dietary Supplement: Protein diet

Interventions

Protein dietDIETARY_SUPPLEMENT

Subjects will receive either a low protein or a high protein diet for 14 days. High protein will be realized with protein supplements.

High proteinLow protein

Eligibility Criteria

Age55 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males
  • Age between 55 and 75 y
  • BMI between 18.5 and 30 kg/m2

You may not qualify if:

  • Lactose intolerance
  • Smoking and alcohol abuse
  • Diabetes
  • Diagnosed GI tract diseases
  • Arthritic conditions
  • A history of neuromuscular problems
  • Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • Use of anticoagulants
  • Participation in exercise program
  • Hypertension, high blood pressure that is above 140/90 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (2)

  • 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

  • Gorissen SH, Horstman AM, Franssen R, Kouw IW, Wall BT, Burd NA, de Groot LC, van Loon LJ. Habituation to low or high protein intake does not modulate basal or postprandial muscle protein synthesis rates: a randomized trial. Am J Clin Nutr. 2017 Feb;105(2):332-342. doi: 10.3945/ajcn.115.129924. Epub 2016 Nov 30.

    PMID: 27903518DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

NL(1)