Clinical trial NCT02281331: Optimal Exercise Training and Nutrition Supplementation in Older Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 50
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle protein synthesis
timeFrame: 12 weeks
measure: Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain
timeFrame: 12 weeks
measure: Glycemic control
timeFrame: 12 weeks
measure: Cognitive function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Univeristy
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.