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Nutritional Management of Post COVID-19 Cognitive Symptoms

Primary Purpose

Long COVID

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
medium chain triglyceride oil
Safflower oil
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring brain fog; confusion; memory loss; functional decline

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Medium chain triglyceride oil 15ml tid x 5 months

Safflower oil 15mls tid x 5 months

Outcomes

Primary Outcome Measures

Cognigram(R)
computer-based cognitive test

Secondary Outcome Measures

Montreal Cognitive Assessment
Cognitive test

Full Information

First Posted
January 27, 2023
Last Updated
October 5, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05705648
Brief Title
Nutritional Management of Post COVID-19 Cognitive Symptoms
Official Title
Nutritional Management of Post COVID-19 Cognitive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Randomized placebo-control clinical trial comparing two types of nutritional oil and evaluating the impact, if any, on subjective complaints of long-COVID cognitive changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID
Keywords
brain fog; confusion; memory loss; functional decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised placebo-controlled clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, placebo control
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Medium chain triglyceride oil 15ml tid x 5 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Safflower oil 15mls tid x 5 months
Intervention Type
Dietary Supplement
Intervention Name(s)
medium chain triglyceride oil
Intervention Description
Medium chain triglyceride oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Safflower oil
Intervention Description
Safflower oil
Primary Outcome Measure Information:
Title
Cognigram(R)
Description
computer-based cognitive test
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Description
Cognitive test
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: COVID infection not confirmed by PCR or Rapid test unable to speak English pre-COVID cognitve complaints, and/or medical diagnoses affecting cognitive function
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Juby, MBChB
Phone
(780) 492-6233
Email
angela.juby@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nutritional Management of Post COVID-19 Cognitive Symptoms

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