Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons

Study Overview
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Brief Summary
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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 can increase muscle strength, function and mass in older adults. The primary aim of this study is to determine whether the combination of resistance training with a supplementation of a cysteine- rich whey protein isolate (Immunocal) compared to combination of resistance training with casein used as control (casein contains little cysteine) could have the potential to provide a synergic beneficial impact on muscle mass and function which could translate to an improved quality of life in elderly persons.

Official Title
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Effect of the Cysteine-rich Whey Protein Isolate (Immunocal®) in Combination With Physical Exercise on Muscle Function, Body Composition and Inflammatory Cytokine Levels in Elderly Persons: A Randomized, Double-blind Study

Conditions
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Aging, Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Immunocal
* Dietary Supplement: Casein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunocal<br>20g of Immunocal | Dietary Supplement: Immunocal<br>* 20 grams per day of Immunocal for 135 days.<br>Dietary Supplement: Casein<br>* 20 grams per day for 135 days<br>|
| Placebo Comparator: Casein<br>20g of Casein | Dietary Supplement: Immunocal<br>* 20 grams per day of Immunocal for 135 days.<br>Dietary Supplement: Casein<br>* 20 grams per day for 135 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment |  | 45, 90, 135 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean of percent change in muscle strength based on hand-grip dynamometer |  | 45, 90 and 135 days | 
| Percent change in lean body mass evaluated by DEXA. |  | 40, 90 and 135 days | 
| The change in the plasma concentrations of Tumor Necrosis Factor-alpha (TNF-alpha), interleukin-6 (IL-6), C-reactive protein (CRP), glutathione, cysteine, asparagine, leucine and albumin |  | 40, 90 and 135 days | 
| The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)). |  | 40, 90 and 135 days | 
| Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model). |  | 40, 90 and 135 days | 
| The % change in body weight. |  | 40, 90 and 135 days | 
| Bone mass density |  | 40, 90 and 135 days | 
| 6-min walk test |  | 40, 90 and 135 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly persons, Muscle function and strength, Body composition, Inflammatory cytokine levels, Cognitive functions, Cysteine-rich whey protein isolate, Immunocal, Resistance training, Improved muscle function, Improved quality of life, Aging processes, Quality of life