Milk and Milk-produce to Counteract the Loss of Muscle Mass and Function in Exercising Older Adults.
PRO
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 3, 2014
December 1, 2014
1.9 years
February 7, 2013
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle mass
At baseline and post intervention (17th week)
Secondary Outcomes (6)
Relative strength
At baseline and post intervention (17th week)
Blood markers of inflammation
At baseline and post intervention (17th week)
Plasma Lipid profile
At baseline and post intervention (17th week)
Plasma creatinine
At baseline, mid (8th week) and post intervention (17th week)
Blood markers of fatty liver
At baseline and post intervention (17th week)
- +1 more secondary outcomes
Other Outcomes (2)
Dietary intakes
At baseline, mid (8th week) and post intervention (17th week)
Physical activity level
At baseline and post intervention (17th week)
Study Arms (3)
Milk proteins
EXPERIMENTALThis group will do a resistance training + milk proteins (milk beverage)
Essential amino acids (add to soya bvg)
EXPERIMENTALThis group will do a resistance training + essential amino acids (added to soya beverage)
No protein (control)
PLACEBO COMPARATORThis group will do a resistance training + ingestion of the control beverage (no protein, rice beverage)
Interventions
All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- major physical disability
- medical treatment influencing metabolism
- statin treatment
- diagnosis or any sign of kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Université de Sherbrookelead
- Dairy Farmers of Canadacollaborator
Study Sites (1)
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle J. Dionne, Ph.D.
Université de Sherbrooke
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2013
First Posted
June 21, 2013
Study Start
May 1, 2012
Primary Completion
April 1, 2014
Study Completion
December 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12