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Exercise and Nutritional Supplementation (ENSASL)

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.
 
ClinicalTrials.gov Identifier: NCT03536871
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Tarnopolsky, McMaster University

Brief Summary:
To understand the effects of a novel dietary supplement when used in conjunction with a healthy lifestyle exercise program and to define biomarkers that are specific to sarcopenia. A primary aim in the present study is to determine whether a relationship exists between positive changes in body composition through increases in lean mass and reductions in body fat following oral supplementation of naturally occurring food components in combination with exercise. The purpose of the present study is to examine the effects of a multi-nutrient supplement in combination with an endurance and resistance based exercise intervention in a cohort of older adult men with varying degrees of sarcopenia as compared to younger male controls (McMaster/CIHR/Exerkine project). A sub-purpose nested within the study is to provide serum and muscle samples for use in an aging/sarcopenia biomarker discovery study taken at pre-intervention for the young and older men (Buck Institute/Astellas project).

Condition or disease Intervention/treatment Phase
Sarcopenia Healthy Elderly Healthy Young Dietary Supplement: multi-nutrient supplement Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Exercise
We will evaluate the effect of 12 weeks of combined endurance and resistance home-based exercise in younger and older adults.




Primary Outcome Measures :
  1. Body Composition [ Time Frame: 12 weeks ]
    Fat-Free and Fat Mass

  2. Muscle Strength [ Time Frame: 12 weeks ]
    Knee extension isometric strength and leg press

  3. Functional Outcomes [ Time Frame: 12 weeks ]
    6 Minute Walk Test


Secondary Outcome Measures :
  1. Mitochondrial Function [ Time Frame: 12 weeks ]
    COX IV Enzyme Activity

  2. Muscle Fibre Size [ Time Frame: 12 weeks ]
    Type I and II fibre size

  3. Inflammatory markers [ Time Frame: 12 weeks ]
    IL-6

  4. Quality of Life assessment [ Time Frame: 12 weeks ]
    SF-36 questionnaire

  5. Glycemia measurements [ Time Frame: 12 weeks ]
    hemoglobin A1C

  6. Plasma lipids [ Time Frame: 12 weeks ]
    Cholesterol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inactive younger men (< 1 hour of formal exercise/week) in the overweight BMI category (25 - 29.9 kg/m2).
  • Healthy older male participants will have a body mass index < 30 kg/m2, muscle mass index > 7.23 kg/m2, and a 4-meter walk test > 0.8 m/s.
  • Men in the older adult "sarcopenia" group will be individuals that have a body mass index < 30 kg/m2, a muscle mass index between 8.51-10.75 kg/m2, and a 4-meter walk test < 0.8m/s.

Exclusion Criteria:

  • Current smokers
  • On more than one anti-diabetic drug
  • Cardiovascular disease (myocardial infarction and/or hypertension requiring more than 2 medications)
  • Congestive heart failure
  • Renal disease (creatinine > 130)
  • Previous stroke
  • Hypertension requiring more than two-pharmacological agents
  • Active musculoskeletal injuries and/or severe osteoarthritis
  • Significant weight loss in the 3-month period prior to the study
  • Vegan diet
  • Dairy protein allergy
  • History of muscle and/or bone wasting diseases
  • Concurrent medications known to affect protein metabolism (i.e. corticosteroids, or prescription strength acne medications)
  • Inability to consent
  • Chronic obstructive pulmonary disease (FVC or FEV1 < 80% of age predicted mean value or requiring any medication other than a puffer as needed)
  • Concurrent supplementation with a dietary protein, calcium, l-leucine, creatine, CoQ10, alpha lipoic acid, n-3 PUFA, and conjugated linoleic acid.

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 ClinicalTrials.gov identifier (NCT number): NCT03536871


Locations
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Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
Publications of Results:

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Responsible Party: Mark Tarnopolsky, Principal Investigator, Professor, Director of Neuromuscular and Neurometabolic Clinic, McMaster University
ClinicalTrials.gov Identifier: NCT03536871    
Other Study ID Numbers: 4656
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Nutrients
Growth Substances
Physiological Effects of Drugs