Use of a Cysteine-rich Whey Protein Isolate in Post COVID-19 Cognitive Impairment

NCT07184398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-24

No results posted yet for this study

Summary

Abstract Background: Post-COVID-19 cognitive impairment (PCCI), characterized by deficits in attention, memory, and executive functioning, remains a major challenge among patients with long COVID. Oxidative stress is a key contributor to this condition. Cysteine-rich whey protein isolate (CRWPI), such as Immunocal®, enhances intracellular glutathione production and may offer neuroprotective benefits.

Objective: To evaluate the efficacy of Immunocal® supplementation on cognitive function, particularly attention and memory, and functional performance in individuals with ICCP.

Methods: A randomized, controlled, parallel-group trial was conducted in Cali, Colombia, with 120 adults recovering from COVID-19 with mild to moderate cognitive impairment. Participants were randomly assigned to three groups: (1) immune® supplementation (CRWPI) (20 g/day), (2) neuropsychological rehabilitation, or (3) no intervention (control), for 12 weeks. Cognitive outcomes were assessed using the Montreal Cognitive Assessment (MoCA) and the NEUROPSI attention and memory test. Physical endurance was measured using the 30-second foot test (STST). Clinical symptoms evaluated through a medical assessment form, before and after the intervention, were also taken into account. Results: Both the Immunocal® and neurorehabilitation groups showed statistically significant improvements in all attention subdomains and memory types compared to the control. Immunocal® produced greater gains in divided attention and working memory, suggesting a specific advantage in cognitive domains sensitive to oxidative stress. STST performance was also significantly improved in the Immunocal® group. No significant improvements were seen in the control group.

Conclusion: Immunocal® supplementation significantly improves cognitive performance, comparable to structured neurorehabilitation, in individuals with ICCP. It also shows potential to improve physical endurance, clinical symptoms, and reduce fatigue. These findings support the integration of Immunocal® as a non-pharmacological intervention for cognitive dysfunction related to long COVID.

Conditions

  • COVID-19 (SARS-CoV-2 Infection)

Interventions

OTHER

Intervention with Consolidated Cysteine (Immunocal) 20 g per day

CRWPI Immunocal® (Immunotec™) was administered at a dose of 20 grams (2 sachets once daily) for 12 consecutive weeks. The research team delivered Immunocal directly to the subjects and instructed them on how to mix and self-administer it.

BEHAVIORAL

Cognitive rehabilitation workshops

Neuropsychological rehabilitation consisted of in-person group sessions for 40 adults (18 years or older) to work on cognitive functions such as memory and attention. Each session lasted 45 minutes. These sessions were held three times a week for a period of 12 weeks.

Sponsors & Collaborators

  • Immunotec Inc.

    collaborator INDUSTRY
  • Universidad Libre seccional Cali

    lead OTHER

Principal Investigators

  • Ingrid Mena, Neuropsychologist · Universidad Libre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-09-30
Completion
2025-01-01

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184398 on ClinicalTrials.gov