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Completed

NCT Number: NCT01883674

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

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.

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Key information

Age range

65 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Other

All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.

Primary outcomes

  1. Muscle mass

    Time frame: At baseline and post intervention (17th week)

Secondary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Acronym: PRO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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