Status:
COMPLETED
Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons
Lead Sponsor:
Immunotec Inc.
Conditions:
Aging
Sarcopenia
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Aging is typically associated with a decrease in skeletal muscle mass and muscle function, which contributes decisively to disability in old age and to the loss of quality of life.Resistance exercise ...
Eligibility Criteria
Inclusion
- Age 65 or older
- Estimated GFR above 45ml/min
- Total bilirubin in the normal range (0.2 to 1.2 mg/dl) AST (10-35 U/L for women and 10-50 U/L for men). ALT equal to or less than 2.5 times the upper limit of normal
- BMI between 18.5-29.9 (kg)/m2
- Sedentary (\< 2 hours of structured exercise)in the last 2 or 3 months
- Based on investigator judgment according to current Canadian guidelines, medical conditions such as hypertension, diabetes and hyperlipidemia have to be stable and optimally controlled before the subject starts the study.
Exclusion
- History of angioedema or allergic reactions to any compound used in this study.
- Milk protein intolerance
- Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements.
- Major surgery in the year prior to testing
- Acute coronary or vascular event within the last year or progressive angina
- Stroke within the past 2 years
- Neurologist and/or orthopedic limitations
- Uncontrolled thyroid or pituitary disease
- Medication which has a major affect on cognitive function
- Signs of early dementia as assessed by Mini-Mental State Examination
- Weight loss of more than 4kg(or more than 5% body weight) over last 6 months
- Alcohol abuse
- Medication which interferes with muscle mass i.e. (corticosteroids)
- Any life threatening conditions based on Investigator judgment.
- Subjects with allergies/intolerance to soya.
- Subjects currently undergoing immunosuppressive therapy.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00935610
Start Date
June 1 2009
End Date
March 1 2014
Last Update
February 9 2021
Active Locations (1)
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1
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7