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

NCT00935610 | Completed Phase 2

• 1 other identifier: AGING-IMM08
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Sarcopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Immunocal

ACTIVE COMPARATOR

20g of Immunocal

Dietary Supplement: Immunocal; Dietary Supplement: Casein

Casein

PLACEBO COMPARATOR

20g of Casein

Dietary Supplement: Immunocal; Dietary Supplement: Casein

Interventions

Immunocal DIETARY_SUPPLEMENT

20 grams per day of Immunocal for 135 days.

Casein; Immunocal

Casein DIETARY_SUPPLEMENT

20 grams per day for 135 days

Casein; Immunocal

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunotec Inc.: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• 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.

  PMID: 25923482 DERIVED

MeSH Terms

Conditions

Sarcopenia

Interventions

Caseins

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Phosphoproteins

Study Officials

• Remi Rabasa-Lhoret, MD. Ph.D.

  Institut de Recherches Cliniques de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: February 9, 2021

Record last verified: 2011-06

Locations

CA (1)