Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health

Study Overview
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Brief Summary
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Alzheimer disease (AD) is a dementing illness characterized by progressive neuronal degeneration, gliosis, and the accumulation of intracellular inclusions and extracellular deposits of amyloid in discrete regions of the basal forebrain, hippocampus, and the association cortices. Mild cognitive impairment (MCI) refers to individuals with cognitive impairment (often memory loss) that fails to meet clinical criteria for AD or another dementing illness.

Official Title
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Nutritional Intervention With the Cysteine-rich Whey Protein Isolate Dietary Supplement Immunocal® in MCI Patients: Promotion of Brain Health & Wellness During Aging and Oxidative Stress

Conditions
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Mild Cognitive Impairment (MCI)

Intervention / Treatment
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* Dietary Supplement: Immunocal


Participation Criteria
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Eligibility Criteria
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This study is recruiting Mild Cognitive Impaired (MCI) patients from the Memory Clinic of the Jewish General Hospital only. Inclusion Criteria: Subjects meeting diagnostic criteria for MCI: Age 55-85 Male or female Non-smoker To ensure that the subject can physically fit in the scanner: body weight ≤ 120 kg and with a linear dimension max 55cm (shoulders or belly) Expected to remain in the greater Montreal area for the duration of study. Exclusion Criteria: Presence of an active, systemic illness (e.g., cancer, rheumatoid arthritis, etc.) or other chronic neurological (e.g. Parkinson's disease, multiple sclerosis) or psychiatric (e.g. major depression, schizophrenia) disease. Subjects taking other experimental medications or psychotropic agents. Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. Ambulatory subjects: As wheelchair-bound subjects present additional difficulties for transportation and MRI scanning. Musculoskeletal abnormalities that preclude the ability of the subject to lie on his/her back for 1hr during MRI scanning. Subjects who have a protein restricted diet as per their medical history. Pregnancy Subjects using N-acetylcysteine, α-lipoic acid supplements, other whey protein supplements or Vitamin C, within 2 months of enrolment and during the entire 6 months study period. Allergies to milk proteins/ Milk protein intolerance

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interventional<br>Immunocal 20gm daily | Dietary Supplement: Immunocal<br>* cysteine-rich whey protein isolate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GSH levels in the brain | Change in cerebral Glutathione levels of MCI patients measured by MRI/MRS scans | Baseline compared to month 6 (180 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma GSH:GSSG ratios measured by HPLC | To evaluate positive correlation between plasma GSH:GSSG ratios and changes in cerebral GSH | Baseline compared to month 6 (180 days) | 
| Evaluation of neuropsychological and cognitive functions | The Memory Clinic of JGH Neuropsychological evaluation questionnaire will be used to measure both neuropsychological and cognitive functions | Baseline compared to month 6 (180 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation