Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men (Pro-Fat)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
- 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)
- 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 |
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| Contact: Stefan H Gorissen, MSc | +31433881810 | stefan.gorissen@maastrichtuniversity.nl |
| 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. | |
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 Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013