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

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ClinicalTrials.gov Identifier: NCT01883674
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
Université de Sherbrooke

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Other: Resistance training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
Study Start Date : May 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2014

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.




Primary Outcome Measures :
  1. Muscle mass [ Time Frame: At baseline and post intervention (17th week) ]

Secondary Outcome Measures :
  1. Relative strength [ Time Frame: At baseline and post intervention (17th week) ]
  2. Blood markers of inflammation [ Time Frame: At baseline and post intervention (17th week) ]
    Plasmatic IL-6 anf TNF-alpha

  3. Plasma Lipid profile [ Time Frame: At baseline and post intervention (17th week) ]
    Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.

  4. Plasma creatinine [ Time Frame: At baseline, mid (8th week) and post intervention (17th week) ]
    Blood marker on renal function will be assessed to ensure the safety of the supplementation of protein intake on renal function in sarcopenic men.

  5. Blood markers of fatty liver [ Time Frame: At baseline and post intervention (17th week) ]
    Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT) and Alkaline phosphatase (ALP).

  6. extracellular HSP72 [ Time Frame: At baseline and post intervention (17th week) ]

Other Outcome Measures:
  1. Dietary intakes [ Time Frame: At baseline, mid (8th week) and post intervention (17th week) ]
    3-day food record - Control variable (in order to verify if changes we observe through the intervention are accountable or not for dietary intakes)

  2. Physical activity level [ Time Frame: At baseline and post intervention (17th week) ]
    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)



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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883674


Locations
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Canada, Quebec
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
Dairy Farmers of Canada
Investigators
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Principal Investigator: Isabelle J. Dionne, Ph.D. Université de Sherbrooke

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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01883674     History of Changes
Other Study ID Numbers: PLC-021742
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Université de Sherbrooke:
Sarcopenia
Physical capacity
Muscle force
Muscle quality
Milk proteins
Essential amino acids
Proteins
Resistance training
Exercise

Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action