Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men (Pro-Fat)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01680146
First received: August 21, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our healthcare system due to increased morbidity and greater need for hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to improve dietary intake of the elderly. It has already been shown that ingestion of dietary protein stimulates muscle protein synthesis and inhibits muscle protein breakdown, resulting in an overall positive net protein balance. However, the impact of fat (as part of the meal) on dietary protein-induced muscle protein synthesis remains largely unknown. Based on previous studies by other research groups, we hypothesize that fat further stimulates the muscle anabolic response to protein ingestion.

Objective: The primary objective of this study is to investigate the effect of a single meal-like amount of protein with or without fat on postprandial muscle protein synthesis rates in healthy elderly men. Furthermore, as a secondary objective, we will assess digestion and absorption kinetics.

Study design: double-blind randomized intervention study Study population: 24 healthy elderly men (55-85 y) Intervention: one group (n=12) will consume a test beverage of 350 mL containing 20 g of intrinsically labeled casein, and the other group (n=12) will consume a beverage of the same volume containing 20 g of casein plus 20 g of fat.

Main study parameters/endpoints: Primary endpoint: muscle protein synthesis rates. Secondary endpoint: digestion and absorption kinetics.


Condition Intervention
Sarcopenia
Dietary Supplement: PRO+FAT
Dietary Supplement: PRO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men (Pro-Fat Study)

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • muscle protein synthesis (MPS) rates [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    The main study endpoint is muscle protein synthesis (MPS) rates. In order to determine the MPS, the following parameters will be measured:

    • Muscle protein-bound L-[1-13C]-phenylalanine, L-[ring-2H5]-phenylalanine, and L-[1-13C]-leucine enrichment (expressed as MPE)
    • Plasma L-[1-13C]-phenylalanine and L-[1-13C]-KIC enrichment (expressed as MPE)
    • Muscle free (intracellular) L-[1-13C]-phenylalanine enrichment (expressed as MPE)


Secondary Outcome Measures:
  • protein digestion and absorption kinetics [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    Secondary endpoints include protein digestion and absorption kinetics. Therefore, the following parameters will be measured:

    • Plasma phenylalanine, tyrosine, and leucine concentration (expressed as μmol/L)
    • Plasma enrichments of:

      • L-[1-13C]-phenylalanine
      • L-[1-13C]-tyrosine
      • L-[1-13C]-leucine
      • L-[ring-2H5]-phenylalanine
      • L-[ring-2H4]-tyrosine
      • L-[ring-2H2]-tyrosine

  • whole-body protein metabolism [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Secondary endpoints include whole-body protein metabolism, which will be calculated based on protein digestion and absorption kinetics.

  • Glucose concentrations [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    During the experimental trial, we will measure glucose concentrations in the obtained plasma samples.

  • Insulin concentrations [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    During the experimental trial, we will measure insulin concentrations in the obtained plasma samples.


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PRO
Subject will only be fed 20 g of casein
Dietary Supplement: PRO
Other Name: 20 g of casein
Experimental: PRO+FAT
Subjects will be fed 20 g of casein plus 20 g of anhydrous milk fat
Dietary Supplement: PRO+FAT
Other Name: 900063 Anhydrous Milk Fat

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males
  • Age between 55 and 85
  • BMI < 30 kg/m2

Exclusion Criteria:

  • Glucose intolerance
  • Milk and/or fat intolerance
  • Smoking
  • 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: NCT01680146

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

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Stefan H Gorissen, MSc    31433881810    stefan.gorissen@maastrichtuniversity.nl   
Principal Investigator: Luc JC van Loon, Prof. Dr.         
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01680146     History of Changes
Other Study ID Numbers: METC 12-3-030
Study First Received: August 21, 2012
Last Updated: October 29, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on October 30, 2014