Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons
This study is ongoing, but not recruiting participants.
Sponsor:
Immunotec Inc.
Information provided by (Responsible Party):
Immunotec Inc.
ClinicalTrials.gov Identifier:
NCT00935610
First received: July 7, 2009
Last updated: January 29, 2013
Last verified: June 2011
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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 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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
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: | January 29, 2013 |
| 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 19, 2013