Optimal Exercise Training and Nutrition Supplementation in Older Men

Not Applicable

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Supplement

• Registration Number: NCT02281331
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

Please see other documentation.

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-11-02
• Primary Completion: 2016-12-01
• Study Completion: 2018-05-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplement	Supplement	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.
Placebo	Supplement	The placebo will provide participants with maltodextrin (carbohydrate) and sucrose.

Primary Outcome Measures

Name	Time	Method
Muscle mass	12 weeks	DXA, ultrasound

Secondary Outcome Measures

Name	Time	Method
Muscle protein synthesis	12 weeks	The incorporation of a stable isotope (deuterium) into muscle tissue will allow for the determination of fractional synthetic rate, which is indicative of muscle protein synthesis.
Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain	12 weeks	Histochemical methods will be used to determine how the supplement and training affect muscle growth and regenerative capacity, specifically the behaviour of satellite cells.
Glycemic control	12 weeks	Oral glucose tolerance test
Cognitive function	12 weeks	Questionnaires and simple computer-based identification, reaction time and memory tasks.

Trial Locations

Locations (1)

McMaster Univeristy; 🇨🇦 Hamilton, Ontario, Canada