Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons - Full Text View

Sponsor:	Immunotec Inc.
Information provided by:	Immunotec Inc.
ClinicalTrials.gov Identifier:	NCT00935610

Purpose

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	Intervention	Phase
Aging Sarcopenia	Dietary Supplement: Immunocal Dietary Supplement: Casein	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Exercise and Physical Fitness

Drug Information available for: Cysteine Casein

U.S. FDA Resources

Further study details as provided by Immunotec Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The mean of percent change in muscle strength based on hand-grip dynamometer [ Time Frame: 45, 90 and 135 days ] [ Designated as safety issue: No ]
Percent change in lean body mass evaluated by DEXA. [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)). [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]
Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model). [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]
The % change in body weight. [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]
Bone mass density [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]
6-min walk test [ Time Frame: 40, 90 and 135 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Dietary Supplement: Immunocal 20 grams per day of Immunocal for 135 days. Dietary Supplement: Casein 20 grams per day for 135 days

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935610

Locations

Canada, Quebec
Institut de recherches cliniques de Montréal	Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Rémi Rabasa-Lhoret, MD PhD 514-343-6111 ext 128840 remi.rabasa-lhoret@ircm.qc.ca
Principal Investigator: Rémi Rabasa-Lhoret, MD PhD

Sponsors and Collaborators

Immunotec Inc.

Investigators

Principal Investigator:

Remi Rabasa-Lhoret, MD. Ph.D.

Institut de Recherches Cliniques de Montreal

More Information

No publications provided

Responsible Party:	Dr. Remi Rabasa-Lhoret MD. Ph.D., Institut de recherches cliniques de Montreal
ClinicalTrials.gov Identifier:	NCT00935610 History of Changes
Other Study ID Numbers:	AGING-IMM08
Study First Received:	July 7, 2009
Last Updated:	June 6, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Immunotec Inc.:

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

Additional relevant MeSH terms:

Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy

Pathological Conditions, Anatomical
Signs and Symptoms
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012