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

NCT ID: NCT03448055

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2023-11-25

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional

Immunocal 20gm daily

Group Type: OTHER

Immunocal

Intervention Type: DIETARY_SUPPLEMENT

cysteine-rich whey protein isolate

Interventions

Immunocal

cysteine-rich whey protein isolate

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunotec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Memory Clinic/Jewish General Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Chris Hosein, M.Ed, CCRP

Role: primary

chosein@jgh.mcgill.ca

514-340-8222 ext. 23621

References

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.

Reference Type: BACKGROUND

PMID: 28603087 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28894506 (View on PubMed)

Other Identifiers

MCI-IMM15

Identifier Type: -

Identifier Source: org_study_id