Clinical trial NCT00935610: Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aging
Sarcopenia
Keywords: 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
Lead sponsor: Immunotec Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 99
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment
timeFrame: 45, 90, 135 days
Secondary outcomes:
measure: The mean of percent change in muscle strength based on hand-grip dynamometer
timeFrame: 45, 90 and 135 days
measure: Percent change in lean body mass evaluated by DEXA.
timeFrame: 40, 90 and 135 days
measure: 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
timeFrame: 40, 90 and 135 days
measure: The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).
timeFrame: 40, 90 and 135 days
measure: Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).
timeFrame: 40, 90 and 135 days
measure: The % change in body weight.
timeFrame: 40, 90 and 135 days
measure: Bone mass density
timeFrame: 40, 90 and 135 days
measure: 6-min walk test
timeFrame: 40, 90 and 135 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de Recherches Cliniques de Montreal
name: Remi Rabasa-Lhoret, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karelis AD, Messier V, Suppere C, Briand P, Rabasa-Lhoret R. Effect of cysteine-rich whey protein (immunocal(R)) supplementation in combination with resistance training on muscle strength and lean body mass in non-frail elderly subjects: a randomized, double-blind controlled study. J Nutr Health Aging. 2015 May;19(5):531-6. doi: 10.1007/s12603-015-0442-y.