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

NCT ID: NCT01883674

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Milk proteins

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

Group Type EXPERIMENTAL

Resistance training

Intervention Type OTHER

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

Essential amino acids (add to soya bvg)

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

Group Type EXPERIMENTAL

Resistance training

Intervention Type OTHER

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

No protein (control)

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

Group Type PLACEBO_COMPARATOR

Resistance training

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance training

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dairy Farmers of Canada

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabelle J. Dionne, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLC-021742

Identifier Type: -

Identifier Source: org_study_id