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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


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Aging, Sarcopenia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Outcome Measure:

The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment

Outcome Time Frame:

45, 90, 135 days

Safety Issue:

No

Principal Investigator

Remi Rabasa-Lhoret, MD. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut de Recherches Cliniques de Montreal

Authority:

Canada: Health Canada

Study ID:

AGING-IMM08

NCT ID:

NCT00935610

Start Date:

June 2009

Completion Date:

October 2013

Related Keywords:

  • Aging
  • Sarcopenia
  • 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
  • Sarcopenia

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