Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons
NCT ID: NCT00935610
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2009-06-30
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Immunocal
20g of Immunocal
Immunocal
20 grams per day of Immunocal for 135 days.
Casein
20 grams per day for 135 days
Casein
20g of Casein
Immunocal
20 grams per day of Immunocal for 135 days.
Casein
20 grams per day for 135 days
Interventions
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Immunocal
20 grams per day of Immunocal for 135 days.
Casein
20 grams per day for 135 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
Yes
Sponsors
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Immunotec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Remi Rabasa-Lhoret, MD. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherches Cliniques de Montreal
Locations
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Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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AGING-IMM08
Identifier Type: -
Identifier Source: org_study_id
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