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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935610
• Other study ID #: AGING-IMM08
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: March 2014

Study information

• Verified date: June 2011
• Source: Immunotec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Sarcopenia

Intervention

Dietary Supplement:
• Immunocal
20 grams per day of Immunocal for 135 days.
• Casein
20 grams per day for 135 days

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Immunotec Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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