Nutritional Management of Post COVID-19 Cognitive Symptoms

NCT05705648 | Recruiting DMC

• 1 other identifier: Pro00109795
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about in brain "fog" complaints associated with long-COVID in people aged 22-50-years. The main questions it aims to answer are:

• the natural course of brain "fog" complaints
• the effect, if any of supplemental dietary oil on brain "fog" complaints Participants will be asked to undergo some brain testing (X-rays and questions. Treatments they'll be given will be one of two supplemental oils to consume daily. Researchers will compare outcomes in the two different oil groups to see if it has any effect on brain "fog" complaints.

Conditions

Long COVID

Keywords

brain fog; confusion; memory loss; functional decline

Outcome Measures

Primary Outcomes (1)

• Cognigram(R)

  computer-based cognitive test

  12-months

Secondary Outcomes (1)

• Montreal Cognitive Assessment

  12-months

Study Arms (2)

Intervention

EXPERIMENTAL

Medium chain triglyceride oil 15ml tid x 5 months

Dietary Supplement: medium chain triglyceride oil

Placebo

PLACEBO COMPARATOR

Safflower oil 15mls tid x 5 months

Dietary Supplement: Safflower oil

Interventions

medium chain triglyceride oil DIETARY_SUPPLEMENT

Medium chain triglyceride oil

Intervention

Safflower oil DIETARY_SUPPLEMENT

Safflower oil

Placebo

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• confirmed COVID infection, at least 3 months previously, with ongoing cognitive complaints
• all other medical conditions stable, and on stable doses of medications (if required)

You may not qualify if:

• COVID infection not confirmed by PCR or Rapid test
• unable to speak English
• pre-COVID cognitve complaints, and/or medical diagnoses affecting cognitive function

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Mental Fatigue; Confusion; Memory Disorders

Interventions

Safflower Oil

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatigue; Signs and Symptoms; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised placebo-controlled clinical trial

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: January 31, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)