This trial is active, not recruiting.

Condition aging
Treatment supplement
Sponsor McMaster University
Start date October 2014
End date October 2016
Trial size 50 participants
Trial identifier NCT02281331, REB 14-677


As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. As the number of seniors increases worldwide, it is becoming more and more important to develop strategies to counteract this loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple lifestyle modifications are the most potent defense strategies. Exercises such as weight lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts of vigorous aerobic exercise interspersed with period of rest, are the most effective in promoting gains in muscle mass and strength. Additionally, components of foods like whey (a protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to independently increase strength. In this study, we are looking to determine how much we can increase muscle strength in older men who are put on an 12 week exercise training program that combines weight lifting and HIIT, and who consume a daily supplement that contains whey protein, creatine, calcium and vitamin D.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
Each day, participants in this group will receive a supplement that provides a total of protein, creatine monohydrate, calcium, vitamin D and carbohydrate. This supplement will be provided to participants in beverage format, twice daily.
supplement/placebo plus exercise training
(Placebo Comparator)
The placebo will provide participants with maltodextrin (carbohydrate) and sucrose.
supplement/placebo plus exercise training

Primary Outcomes

Muscle mass
time frame: 12 weeks

Secondary Outcomes

Muscle protein synthesis
time frame: 12 weeks
Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
time frame: 12 weeks
Glycemic control
time frame: 12 weeks
Cognitive function
time frame: 12 weeks

Eligibility Criteria

Male participants at least 60 years old.

Inclusion Criteria: - Sedentary (no participation in a structured exercise training program in past 6 months) - BMI between 18.5-30.0 kg/m2 - Weight stable for past 6 months - Normal resting blood pressure, or stage I hypertension Exclusion Criteria: - Smoking - Use of simvastatin or atorvastatin - Use of non-steroidal anti-inflammatory drugs - Injuries that prevent safe-participation in an exercise training program - Prescription blood thinners - Diabetes or other metabolic disorders - Cardiac or gastro-intestinal problems - Infectious disease or cancer

Additional Information

Official title Evaluation of the Effects of a Combined Resistance and High-intensity Interval Exercise Training Program, Along With Nutritional Supplementation, on Strength and Physical Function in Older Men
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by McMaster University.