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

NCT03448055 | Unknown

• 1 other identifier: MCI-IMM15
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

MCI, AD, MRI, GSH, Immunocal, brain health, neuropsychological evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in plasma GSH:GSSG ratios measured by HPLC

  Baseline compared to month 6 (180 days)

• Evaluation of neuropsychological and cognitive functions

  Baseline compared to month 6 (180 days)

Study Arms (1)

Interventional

OTHER

Immunocal 20gm daily

Dietary Supplement: Immunocal

Interventions

Immunocal DIETARY_SUPPLEMENT

cysteine-rich whey protein isolate

Interventional

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunotec Inc.: lead

Study Sites (1)

Memory Clinic/Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 28603087 BACKGROUND

• 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.

  PMID: 28894506 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Glucocorticoid-Remediable Aldosteronism

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Nutritional supplemetation with Immunocal 20gm daily for 6 months (180 days)

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 27, 2018
• Study Start: February 5, 2018
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2023
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)