Habitual Protein Intake and Muscle Protein Synthesis (Pro-Hab)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01986842
First received: November 12, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Sarcopenia
Dietary Supplement: Protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Impact of Habitual Dietary Protein Intake on the Anabolic Response in Elderly Men

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Muscle protein synthesis rates [ Time Frame: 0-5 h postprandial period ] [ Designated as safety issue: No ]
    Change in MPS rates during the postprandial phase when compared with the basal phase


Secondary Outcome Measures:
  • Digestion/Absorption kinetics [ Time Frame: 0-5 h postprandial period ] [ Designated as safety issue: No ]
    Difference in digestion of the intrinsically labeled protein after a 14-day period of high vs. low protein diet


Other Outcome Measures:
  • Plasma insulin [ Time Frame: 0-5 h postprandial period ] [ Designated as safety issue: No ]
  • Plasma amino acid concentrations [ Time Frame: 0-5 h postprandial period ] [ Designated as safety issue: No ]
  • Whole-body protein metabolism [ Time Frame: 0-5 h postprandial period ] [ Designated as safety issue: No ]
    Protein metabolism (breakdown, synthesis, oxidation, net balance)


Estimated Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low protein
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
Experimental: High protein
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986842

Contacts
Contact: Stefan H Gorissen, MSc +31433881810 stefan.gorissen@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Not yet recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Stefan H Gorissen, MSc    +31433881810    stefan.gorissen@maastrichtuniversity.nl   
Principal Investigator: Luc JC van Loon, PhD         
Sub-Investigator: Stefan H Gorissen, MSc         
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01986842     History of Changes
Other Study ID Numbers: METC 13-3-050
Study First Received: November 12, 2013
Last Updated: November 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Muscle protein synthesis
Digestion and absorption kinetics
Leucine
Whey protein

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014