Optimal Exercise Training and Nutrition Supplementation in Older Men
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
November 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedAugust 16, 2018
August 1, 2018
2.2 years
October 8, 2014
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Muscle mass
DXA, ultrasound
12 weeks
Secondary Outcomes (4)
Muscle protein synthesis
12 weeks
Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
12 weeks
Glycemic control
12 weeks
Cognitive function
12 weeks
Study Arms (2)
Supplement
ACTIVE COMPARATOREach 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
PLACEBO COMPARATORThe placebo will provide participants with maltodextrin (carbohydrate) and sucrose.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster Univeristy
Hamilton, Ontario, L8S 4K1, Canada
Related Publications (4)
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.
PMID: 31143111DERIVEDBell 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.
PMID: 31032258DERIVEDSnijders 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.
PMID: 29878269DERIVEDBell 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.
PMID: 28719669DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Phillips, PhD
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 8, 2014
First Posted
November 3, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2016
Study Completion
May 1, 2018
Last Updated
August 16, 2018
Record last verified: 2018-08