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

NCT01680146 | Completed

• 1 other identifier: METC 12-3-030
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• muscle protein synthesis (MPS) rates

  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)

  1 day

Secondary Outcomes (4)

• protein digestion and absorption kinetics

  1 day

• whole-body protein metabolism

  1 day

• Glucose concentrations

  1 day

• Insulin concentrations

  1 day

Study Arms (2)

PRO

ACTIVE COMPARATOR

Subjects will ingest 20 g of intrinsically labeled casein dissolved in water

Dietary Supplement: PRO

PRO+FAT

EXPERIMENTAL

Subjects will ingest 20 g of intrinsically labeled casein plus 26.7 g of anhydrous milk fat dissolved in water

Dietary Supplement: PRO+FAT

Interventions

PRO+FAT DIETARY_SUPPLEMENT

Also known as: 20 g of casein + 26.7 g Anhydrous Milk Fat

PRO+FAT

PRO DIETARY_SUPPLEMENT

Also known as: 20 g of casein

PRO

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

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: 32069356 DERIVED

• Gorissen SHM, Burd NA, Kramer IF, van Kranenburg J, Gijsen AP, Rooyackers O, van Loon LJC. Co-ingesting milk fat with micellar casein does not affect postprandial protein handling in healthy older men. Clin Nutr. 2017 Apr;36(2):429-437. doi: 10.1016/j.clnu.2015.12.011. Epub 2015 Dec 24.

  PMID: 26774526 DERIVED

Related Links

• Research group website

MeSH Terms

Conditions

Sarcopenia

Interventions

Caseins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Officials

• Luc JC van Loon, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: September 7, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

NL (1)