AgingPhase 2NCT00935610
Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons
A Phase 2 study testing Immunocal and Casein in people with Aging and Sarcopenia, run by Immunotec Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia
- What is being tested?
- Immunocal and Casein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
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
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
- Being tested
- Immunocal, Casein
- 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
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunocalDietary supplement
20 grams per day of Immunocal for 135 days.
CaseinDietary supplement
20 grams per day for 135 days
| Study group | Role | What they receive |
|---|---|---|
| Immunocal | Active comparator | 20g of Immunocal Receives: Dietary Supplement: Immunocal; Dietary Supplement: Casein |
| Casein | Placebo comparator | 20g of Casein Receives: Dietary Supplement: Immunocal; Dietary Supplement: Casein |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment
Measured: 45, 90, 135 days
Secondary outcomes (8)
The mean of percent change in muscle strength based on hand-grip dynamometer
Measured: 45, 90 and 135 days
Percent change in lean body mass evaluated by DEXA.
Measured: 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
Measured: 40, 90 and 135 days
The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).
Measured: 40, 90 and 135 days
Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).
Measured: 40, 90 and 135 days
The % change in body weight.
Measured: 40, 90 and 135 days
Bone mass density
Measured: 40, 90 and 135 days
6-min walk test
Measured: 40, 90 and 135 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Remi Rabasa-Lhoret, MD. Ph.D., Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935610
- Sponsor's protocol ID
- AGING-IMM08
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2009
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00935610
- Acronym / sponsor ID
- AGING-IMM08
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Immunotec Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocal | Active comparator | Dietary Supplement: Immunocal, Dietary Supplement: Casein20g of Immunocal |
| Casein | Placebo comparator | Dietary Supplement: Immunocal, Dietary Supplement: Casein20g of Casein |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunocal20 grams per day of Immunocal for 135 days. | Dietary supplement | Casein, Immunocal |
| Casein20 grams per day for 135 days | Dietary supplement | Casein, Immunocal |
Primary outcome
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
8 secondary outcomes
The mean of percent change in muscle strength based on hand-grip dynamometer
Time frame: 45, 90 and 135 days
Percent change in lean body mass evaluated by DEXA.
Time frame: 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
Time frame: 40, 90 and 135 days
The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).
Time frame: 40, 90 and 135 days
Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).
Time frame: 40, 90 and 135 days
The % change in body weight.
Time frame: 40, 90 and 135 days
Bone mass density
Time frame: 40, 90 and 135 days
6-min walk test
Time frame: 40, 90 and 135 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 25923482Karelis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remi Rabasa-Lhoret, MD. Ph.D. principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunocal and Casein in people with Aging and Sarcopenia, run by Immunotec Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.