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

Mild Cognitive Impairment (MCI) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448055
• Other study ID #: MCI-IMM15
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: November 25, 2023

Study information

• Verified date: February 2021
• Source: Immunotec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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, a-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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment (MCI)

Intervention

Dietary Supplement:
• Immunocal
cysteine-rich whey protein isolate

Locations

Country	Name	City	State
Canada	Memory Clinic/Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Immunotec Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Song W, Tavitian A, Cressatti M, Galindez C, Liberman A, Schipper HM. Cysteine-rich whey protein isolate (Immunocal®) 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. — View Citation

Winter AN, Ross EK, Daliparthi V, Sumner WA, Kirchhof DM, Manning E, Wilkins HM, Linseman DA. A Cystine-Rich Whey Supplement (Immunocal®) 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)