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

Sarcopenia Clinical Trial

— PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883674
• Other study ID #: PLC-021742
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: December 1, 2014
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Canada	Centre de recherche sur le vieillissement	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Other	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)	No
Primary	Muscle mass		At baseline and post intervention (17th week)	No
Secondary	Relative strength		At baseline and post intervention (17th week)	No
Secondary	Blood markers of inflammation	Plasmatic IL-6 anf TNF-alpha	At baseline and post intervention (17th week)	No
Secondary	Plasma Lipid profile	Apolipoproteins (Apo-AI, Apo-AII, Apo-B); Total cholesterol, HDL, LDL and triglycerides.	At baseline and post intervention (17th week)	No
Secondary	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)	Yes
Secondary	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)	No
Secondary	extracellular HSP72		At baseline and post intervention (17th week)	No