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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Immunotec Inc.
ClinicalTrials.gov Identifier:
NCT00935610
First received: July 7, 2009
Last updated: May 29, 2014
Last verified: June 2011
  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:


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
Study Completion Date: March 2014
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7
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: Immunotec Inc.
ClinicalTrials.gov Identifier: NCT00935610     History of Changes
Other Study ID Numbers: AGING-IMM08
Study First Received: July 7, 2009
Last Updated: May 29, 2014
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
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014