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CompletedNCT00935610Updated Feb 9, 2021

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

A Phase 2 interventional study of Immunocal and Casein in Aging and Sarcopenia, sponsored by Immunotec Inc.. Completed at 1 site in Canada. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Immunotec Inc. · Phase 2, Interventional, and Health services research

Phase
Phase 2
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aging
  • Sarcopenia

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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
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    Immunocal

    20g of Immunocal

    Dietary Supplement: Immunocal · Dietary Supplement: Casein

  • Placebo comparator
    Casein

    20g of Casein

    Dietary Supplement: Immunocal · Dietary Supplement: Casein

Interventions

  • Dietary supplementImmunocal

    20 grams per day of Immunocal for 135 days.

  • Dietary supplementCasein

    20 grams per day for 135 days

05

What researchers measure

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

06

Study locations

1 site
  • Institut de recherches cliniques de Montréal
    Montreal, Quebec H2W 1R7, Canada
07

References and documents

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. PubMed 25923482 ↗
08

Registry details

Key details

Study ID
NCT00935610
Lead sponsor
Immunotec Inc.
Responsible party
Sponsor
First posted
Jul 9, 2009
Start date
Jun 2009
Primary completion
Jul 2013
Completion
Mar 2014
Last update
Feb 9, 2021

Study contacts

Remi Rabasa-Lhoret, MD. Ph.D.
principal investigator · Institut de Recherches Cliniques de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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