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Optimal Exercise Training and Nutrition Supplementation in Older Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02281331
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : August 16, 2018
Information provided by (Responsible Party):
Stuart Phillips, 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.

Condition or disease Intervention/treatment Phase
Aging Dietary Supplement: Supplement Not Applicable

Detailed Description:
Please see other documentation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: Supplement
supplement/placebo plus exercise training

Placebo Comparator: Placebo
The placebo will provide participants with maltodextrin (carbohydrate) and sucrose.
Dietary Supplement: Supplement
supplement/placebo plus exercise training

Primary Outcome Measures :
  1. Muscle mass [ Time Frame: 12 weeks ]
    DXA, ultrasound

Secondary Outcome Measures :
  1. Muscle protein synthesis [ Time Frame: 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.

  2. Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain [ Time Frame: 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.

  3. Glycemic control [ Time Frame: 12 weeks ]
    Oral glucose tolerance test

  4. Cognitive function [ Time Frame: 12 weeks ]
    Questionnaires and simple computer-based identification, reaction time and memory tasks.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02281331

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Canada, Ontario
McMaster Univeristy
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
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Principal Investigator: Stuart Phillips, PhD McMaster University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stuart Phillips, Principal Investigator, McMaster University Identifier: NCT02281331    
Other Study ID Numbers: REB 14-677
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018