Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults. (PRO)

This project evaluates the use of different types of proteins from various food sources after an exercise session, on muscle mass and physical capacity in aged sarcopenic men (who have low muscle mass). Specifically, researchers want to:

• Examine the efficiency of protein intake after exercise on muscle mass and physical abilities;
• Examine the impact of exercise and proteins on blood lipids (LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides);
• Examine the impact of exercise and proteins on liver enzymes;
• Examine the impact of exercise and proteins on a hormone that controls hunger;
• Evaluate the program's impact on the ability of the body to produce energy.

All participants are exercising (resistance training) and ingest one of the 3 different sources of proteins, immediately after training:

• Milk proteins (from milk beverage)
• Essential amino acids (added to a soya beverage)
• No protein (rice beverage - control group)

Our hypothesis is that proteins from milk will induce a gain in muscle mass and physical function equivalent to the essential amino acids (EAA). We anticipate that both milk proteins and EAA will be both superior to control group.

This would represent an interesting finding since milk is more accessible, palatable and cheaper than essential amino acids commercial mix.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Centre de recherche sur le vieillissement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 65-75 years
• francophone or understanding French
• muscle mass index < 10.75 kg/m2 (Janssen et al, 2004)
• body mass index <30kg/m²
• weight stable (< 2 kg) for 6 mo
• no resistance exercise for 3 years
• controlled blood pressure for at least 6 months

Exclusion Criteria:

• major physical disability
• medical treatment influencing metabolism
• statin treatment
• diagnosis or any sign of kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk proteins; This group will do a resistance training + milk proteins (milk beverage)	Other: Resistance training; All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
Experimental: Essential amino acids (add to soya bvg); This group will do a resistance training + essential amino acids (added to soya beverage)	Other: Resistance training; All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
Placebo Comparator: No protein (control); This group will do a resistance training + ingestion of the control beverage (no protein, rice beverage)	Other: Resistance training; All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Muscle mass	At baseline and post intervention (17th week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative strength		At baseline and post intervention (17th week)
Blood markers of inflammation	Plasmatic IL-6 anf TNF-alpha	At baseline and post intervention (17th week)
Plasma Lipid profile	Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.	At baseline and post intervention (17th week)
Plasma creatinine	Blood marker on renal function will be assessed to ensure the safety of the supplementation of protein intake on renal function in sarcopenic men.	At baseline, mid (8th week) and post intervention (17th week)
Blood markers of fatty liver	Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT) and Alkaline phosphatase (ALP).	At baseline and post intervention (17th week)
extracellular HSP72		At baseline and post intervention (17th week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intakes	3-day food record - Control variable (in order to verify if changes we observe through the intervention are accountable or not for dietary intakes)	At baseline, mid (8th week) and post intervention (17th week)
Physical activity level	Physical Activity Scale for the Elderly (PASE) - Control variable (in order to verify if changes we observe through the intervention are accountable or not for daily physical activity level)	At baseline and post intervention (17th week)

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Dairy Farmers of Canada
• Investigators: Principal Investigator: Isabelle J. Dionne, Ph.D., Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; Sarcopenia; Resistance training; Physical capacity; Proteins; Essential amino acids; Muscle quality; Milk proteins; Muscle force
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: PLC-021742