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
Among 40 studies in Sarcopenia with a site in Canada — 7 open to participants now, 9 under way, none of them phase 3. Sarcopenia · Canada.
Among the 40 studies in Sarcopenia with a site in Canada, this one is the 6th largest by enrollment of the 35 interventional ones that give a count, is the only one that started in 2009, is one of 4 in phase 2, and was the 3rd registered.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
Browse Sarcopenia studies →7 of the 40 studies in Sarcopenia with a site in Canada are open now. Recruiting first, the newest first:
British Columbia Cancer Agency · Sites in Canada
Seven Oaks Hospital Chronic Disease Innovation Centre · Sites in Canada
University of Saskatchewan · Sites in Canada
University of Regina · Sites in Canada
McMaster University · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2009.
This study's enrollment of 99 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.
Median enrollment 40 across the 35 interventional studies, 146 across the 5 observational. Of the 24 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 40 have an industry lead sponsor. The 10 most frequent:
Immunotec Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Immunotec Inc. has 1 study filed under Sarcopenia — fewer than ten, so there is no comparison to draw.
3 of the studies in Sarcopenia with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06630949McMaster UniversityD3-Creatine and Skeletal Muscle in Older Adults | 2026-12-31 |
| NCT07805993Seven Oaks Hospital Chronic Disease Innovation CentreFeasibility of Egg White Pudding Supplementation for Individuals in Personal Care Home Centres Needing Dietary Supplementation | 2027-02 |
| NCT07625202University of SaskatchewanCreatine Supplementation During GLP-1a Therapy | 2027-05-30 |
Among the 40 studies in Sarcopenia with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20g of Immunocal
Dietary Supplement: Immunocal · Dietary Supplement: Casein
20g of Casein
Dietary Supplement: Immunocal · Dietary Supplement: Casein
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
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
The record gives a start of Jun 2009, a primary completion of Jul 2013 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Whey Protein Isolate · Caseins
Immunotec Inc.