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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Maastricht University Medical Center
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

August 21, 2012
October 29, 2012
October 2012
February 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01680146 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men
Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men (Pro-Fat Study)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Sarcopenia
  • Dietary Supplement: PRO+FAT
    Other Name: 900063 Anhydrous Milk Fat
  • Dietary Supplement: PRO
    Other Name: 20 g of casein
  • Active Comparator: PRO
    Subject will only be fed 20 g of casein
    Intervention: Dietary Supplement: PRO
  • Experimental: PRO+FAT
    Subjects will be fed 20 g of casein plus 20 g of anhydrous milk fat
    Intervention: Dietary Supplement: PRO+FAT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
October 2014
February 2013   (final data collection date for primary outcome measure)

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.
Male
55 Years to 85 Years
Yes
Contact: Stefan H Gorissen, MSc +31433881810 stefan.gorissen@maastrichtuniversity.nl
Netherlands
 
NCT01680146
METC 12-3-030
Not Provided
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Not Provided
Maastricht University Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP