Optimal Exercise Training and Nutrition Supplementation in Older Men
August 14, 2018 updated by: Stuart Phillips, McMaster University
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
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.
Study Overview
Detailed Description
Please see other documentation.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- McMaster Univeristy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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supplement/placebo plus exercise training
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Placebo Comparator: Placebo
The placebo will provide participants with maltodextrin (carbohydrate) and sucrose.
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supplement/placebo plus exercise training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle mass
Time Frame: 12 weeks
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DXA, ultrasound
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle protein synthesis
Time Frame: 12 weeks
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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.
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12 weeks
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Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
Time Frame: 12 weeks
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Histochemical methods will be used to determine how the supplement and training affect muscle growth and regenerative capacity, specifically the behaviour of satellite cells.
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12 weeks
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Glycemic control
Time Frame: 12 weeks
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Oral glucose tolerance test
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12 weeks
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Cognitive function
Time Frame: 12 weeks
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Questionnaires and simple computer-based identification, reaction time and memory tasks.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Phillips, PhD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bell KE, Fang H, Snijders T, Allison DJ, Zulyniak MA, Chabowski A, Parise G, Phillips SM, Heisz JJ. A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases N-3 Index in Healthy Older Men: A Randomized Controlled Trial. Front Aging Neurosci. 2019 May 9;11:107. doi: 10.3389/fnagi.2019.00107. eCollection 2019. Erratum In: Front Aging Neurosci. 2020 Oct 27;12:611387.
- Bell KE, Brook MS, Snijders T, Kumbhare D, Parise G, Smith K, Atherton PJ, Phillips SM. Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise With and Without Multi-ingredient Supplementation in Overweight Older Men. Front Nutr. 2019 Apr 11;6:40. doi: 10.3389/fnut.2019.00040. eCollection 2019. Erratum In: Front Nutr. 2020 Oct 30;7:611389.
- Snijders T, Bell KE, Nederveen JP, Saddler NI, Mazara N, Kumbhare DA, Phillips SM, Parise G. Ingestion of a Multi-Ingredient Supplement Does Not Alter Exercise-Induced Satellite Cell Responses in Older Men. J Nutr. 2018 Jun 1;148(6):891-899. doi: 10.1093/jn/nxy063.
- Bell KE, Snijders T, Zulyniak M, Kumbhare D, Parise G, Chabowski A, Phillips SM. A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. PLoS One. 2017 Jul 18;12(7):e0181387. doi: 10.1371/journal.pone.0181387. eCollection 2017. Erratum In: PLoS One. 2020 Dec 15;15(12):e0243876.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
October 8, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimate)
November 2, 2014
Study Record Updates
Last Update Posted (Actual)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- REB 14-677
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.