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OpenTrials
Completed

NCT Number: NCT00935610

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immunocal

Dietary Supplement

20 grams per day of Immunocal for 135 days.

Casein

Dietary Supplement

20 grams per day for 135 days

Primary outcomes

  1. 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

Secondary outcomes

  1. The mean of percent change in muscle strength based on hand-grip dynamometer

    Time frame: 45, 90 and 135 days

  2. Percent change in lean body mass evaluated by DEXA.

    Time frame: 40, 90 and 135 days

  3. 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

  4. The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).

    Time frame: 40, 90 and 135 days

  5. Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).

    Time frame: 40, 90 and 135 days

  6. The % change in body weight.

    Time frame: 40, 90 and 135 days

  7. Bone mass density

    Time frame: 40, 90 and 135 days

  8. 6-min walk test

    Time frame: 40, 90 and 135 days

Sponsors and collaborators

Lead sponsor

Immunotec Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 9, 2009
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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