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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Resistance training
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, Physical capacity, Muscle force, Muscle quality, Milk proteins, Essential amino acids, Proteins, Resistance training, Exercise

Eligibility Criteria

65 Years - 75 Years (Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de recherche sur le vieillissement

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Milk proteins

Essential amino acids (add to soya bvg)

No protein (control)

Arm Description

This group will do a resistance training + milk proteins (milk beverage)

This group will do a resistance training + essential amino acids (added to soya beverage)

This group will do a resistance training + ingestion of the control beverage (no protein, rice beverage)

Outcomes

Primary Outcome Measures

Muscle mass

Secondary Outcome Measures

Relative strength
Blood markers of inflammation
Plasmatic IL-6 anf TNF-alpha
Plasma Lipid profile
Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.
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.
Blood markers of fatty liver
Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT) and Alkaline phosphatase (ALP).
extracellular HSP72

Full Information

First Posted
February 7, 2013
Last Updated
December 1, 2014
Sponsor
Université de Sherbrooke
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01883674
Brief Title
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
Acronym
PRO
Official Title
Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Dairy Farmers of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Physical capacity, Muscle force, Muscle quality, Milk proteins, Essential amino acids, Proteins, Resistance training, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk proteins
Arm Type
Experimental
Arm Description
This group will do a resistance training + milk proteins (milk beverage)
Arm Title
Essential amino acids (add to soya bvg)
Arm Type
Experimental
Arm Description
This group will do a resistance training + essential amino acids (added to soya beverage)
Arm Title
No protein (control)
Arm Type
Placebo Comparator
Arm Description
This group will do a resistance training + ingestion of the control beverage (no protein, rice beverage)
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
Primary Outcome Measure Information:
Title
Muscle mass
Time Frame
At baseline and post intervention (17th week)
Secondary Outcome Measure Information:
Title
Relative strength
Time Frame
At baseline and post intervention (17th week)
Title
Blood markers of inflammation
Description
Plasmatic IL-6 anf TNF-alpha
Time Frame
At baseline and post intervention (17th week)
Title
Plasma Lipid profile
Description
Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.
Time Frame
At baseline and post intervention (17th week)
Title
Plasma creatinine
Description
Blood marker on renal function will be assessed to ensure the safety of the supplementation of protein intake on renal function in sarcopenic men.
Time Frame
At baseline, mid (8th week) and post intervention (17th week)
Title
Blood markers of fatty liver
Description
Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma-glutamyltransferase (GGT) and Alkaline phosphatase (ALP).
Time Frame
At baseline and post intervention (17th week)
Title
extracellular HSP72
Time Frame
At baseline and post intervention (17th week)
Other Pre-specified Outcome Measures:
Title
Dietary intakes
Description
3-day food record - Control variable (in order to verify if changes we observe through the intervention are accountable or not for dietary intakes)
Time Frame
At baseline, mid (8th week) and post intervention (17th week)
Title
Physical activity level
Description
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)
Time Frame
At baseline and post intervention (17th week)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle J. Dionne, Ph.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

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