Clinical trial NCT03448055: Nutritional Intervention With the Dietary Supplement, Immunocal® in MCI Patients: Promotion of Brain Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation
Lead sponsor: Immunotec Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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:

1. body weight ≤ 120 kg and
2. 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

Primary outcomes:
measure: Change in GSH levels in the brain
timeFrame: Baseline compared to month 6 (180 days)
Secondary outcomes:
measure: Change in plasma GSH:GSSG ratios measured by HPLC
timeFrame: Baseline compared to month 6 (180 days)
measure: Evaluation of neuropsychological and cognitive functions
timeFrame: Baseline compared to month 6 (180 days)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Memory Clinic/Jewish General Hospital
state: Quebec
Study officials:
References:
citation: Song W, Tavitian A, Cressatti M, Galindez C, Liberman A, Schipper HM. Cysteine-rich whey protein isolate (Immunocal(R)) ameliorates deficits in the GFAP.HMOX1 mouse model of schizophrenia. Free Radic Biol Med. 2017 Sep;110:162-175. doi: 10.1016/j.freeradbiomed.2017.05.025. Epub 2017 Jun 8.
citation: Winter AN, Ross EK, Daliparthi V, Sumner WA, Kirchhof DM, Manning E, Wilkins HM, Linseman DA. A Cystine-Rich Whey Supplement (Immunocal(R)) Provides Neuroprotection from Diverse Oxidative Stress-Inducing Agents In Vitro by Preserving Cellular Glutathione. Oxid Med Cell Longev. 2017;2017:3103272. doi: 10.1155/2017/3103272. Epub 2017 Aug 15.