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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Aging
• Intervention / Treatment: Dietary supplement: Immunocal; Dietary supplement: Casein

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immunocal; 20g of 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; 20g of Casein	Dietary supplement: Immunocal; 20 grams per day of Immunocal for 135 days.; Dietary supplement: Casein; 20 grams per day for 135 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment	45, 90, 135 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The mean of percent change in muscle strength based on hand-grip dynamometer	45, 90 and 135 days
Percent change in lean body mass evaluated by DEXA.	40, 90 and 135 days
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	40, 90 and 135 days
The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).	40, 90 and 135 days
Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).	40, 90 and 135 days
The % change in body weight.	40, 90 and 135 days
Bone mass density	40, 90 and 135 days
6-min walk test	40, 90 and 135 days

Collaborators and Investigators

• Sponsor: Immunotec Inc.
• Investigators: Principal Investigator: Remi Rabasa-Lhoret, MD. Ph.D., Institut de Recherches Cliniques de Montreal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 7, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Quality of life; Body composition; Resistance training; Cognitive functions; Immunocal; Elderly persons; Muscle function and strength; Inflammatory cytokine levels; Cysteine-rich whey protein isolate; Improved muscle function; Improved quality of life; Aging processes
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: AGING-IMM08