Exercise and Nutritional Supplementation (ENSASL)
|ClinicalTrials.gov Identifier: NCT03536871|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia Healthy Elderly Healthy Young||Dietary Supplement: multi-nutrient supplement Other: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The nutritional supplement will be delivered to a 3rd party contract research organization and the allocation will only be un-blinded after data lock.|
|Official Title:||Exercise and Nutritional Supplementation for Aging and Sedentary Lifestyles|
|Actual Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Active Comparator: Multinutrient Supplement
Participants will be allocated in a randomized double-masked manner to receive a multi-nutrient supplement (protein and creatine sachet and omega-3 oil) or placebo during a 12 week home-based exercise program and we will assess the influence on the primary and secondary outcomes.
Dietary Supplement: multi-nutrient supplement
Compare the effects of a multi-nutrient supplement following a healthy lifestyles program in healthy young men and women, healthy older men, and sarcopenic older men.
No Intervention: Age biological and chronological
The primary and secondary outcomes will be compared between the younger and older age groups as a function of both exercise and nutritional supplementation.
No Intervention: Sarcopenia grades
The baseline primary and secondary outcomes will be compared for each of the 3 older adults males groups as a function of muscle mass (healthy active, mild sarcopenia and moderate sarcopenia).
Experimental: Exercise - home based programme
Each of the older participants will undergo a 12 week home-based exercise program (endurance = increased steps; resistance = body weight and elastic band exercise) to determine the effects on the primary and secondary outcomes.
We will evaluate the effect of 12 weeks of combined endurance and resistance home-based exercise in younger and older adults.
- Body Composition [ Time Frame: 12 weeks ]Fat-Free and Fat Mass
- Muscle Strength [ Time Frame: 12 weeks ]Knee extension isometric strength and leg press
- Functional Outcomes [ Time Frame: 12 weeks ]6 Minute Walk Test
- Mitochondrial Function [ Time Frame: 12 weeks ]COX IV Enzyme Activity
- Muscle Fibre Size [ Time Frame: 12 weeks ]Type I and II fibre size
- Inflammatory markers [ Time Frame: 12 weeks ]IL-6
- Quality of Life assessment [ Time Frame: 12 weeks ]SF-36 questionnaire
- Glycemia measurements [ Time Frame: 12 weeks ]hemoglobin A1C
- Plasma lipids [ Time Frame: 12 weeks ]Cholesterol
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536871
|McMaster University Medical Center|
|Hamilton, Ontario, Canada, L8N 3Z5|