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

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. Identifier: NCT00935610
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Immunotec Inc.

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 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.

Condition or disease Intervention/treatment Phase
Aging Sarcopenia Dietary Supplement: Immunocal Dietary Supplement: Casein Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Active Comparator: Immunocal
20g of Immunocal
Dietary Supplement: Immunocal
20 grams per day of Immunocal for 135 days.

Dietary Supplement: Casein
20 grams per day for 135 days

Placebo Comparator: Casein
20g of Casein
Dietary Supplement: Immunocal
20 grams per day of Immunocal for 135 days.

Dietary Supplement: Casein
20 grams per day for 135 days

Primary Outcome Measures :
  1. The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment [ Time Frame: 45, 90, 135 days ]

Secondary Outcome Measures :
  1. The mean of percent change in muscle strength based on hand-grip dynamometer [ Time Frame: 45, 90 and 135 days ]
  2. Percent change in lean body mass evaluated by DEXA. [ Time Frame: 40, 90 and 135 days ]
  3. 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 [ Time Frame: 40, 90 and 135 days ]
  4. The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)). [ Time Frame: 40, 90 and 135 days ]
  5. Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model). [ Time Frame: 40, 90 and 135 days ]
  6. The % change in body weight. [ Time Frame: 40, 90 and 135 days ]
  7. Bone mass density [ Time Frame: 40, 90 and 135 days ]
  8. 6-min walk test [ Time Frame: 40, 90 and 135 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00935610

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Canada, Quebec
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
Sponsors and Collaborators
Immunotec Inc.
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Principal Investigator: Remi Rabasa-Lhoret, MD. Ph.D. Institut de Recherches Cliniques de Montreal

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Immunotec Inc. Identifier: NCT00935610     History of Changes
Other Study ID Numbers: AGING-IMM08
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: June 2011

Keywords provided by Immunotec Inc.:
Cysteine-rich whey protein isolate
Elderly persons
Muscle function and strength
Body composition
Inflammatory cytokine levels
Cognitive functions
Resistance training
Improved muscle function
Improved quality of life
Aging processes
Quality of life

Additional relevant MeSH terms:
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Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action