Nutritional Management of Post COVID-19 Cognitive Symptoms | NCT05705648

Studies
Nutritional Management of Post COVID-19 Cognitive Symptoms

NCT05705648

Sponsor

University of Alberta

Status

Recruiting

Last Update Posted

Jul 8, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Long COVID

Interventions

medium chain triglyceride oil
Safflower oil

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Jan 27, 2023

First Posted Date

Jan 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
medium chain triglyceride oil	Dietary Supplement	Medium chain triglyceride oil	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognigram(R)	computer-based cognitive test	12-months

Secondary Outcomes

Measure	Description	Time Frame
Montreal Cognitive Assessment	Cognitive test	12-months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta	Recruiting	Edmonton	Alberta	T6G 2P4	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome
D005222	Mental Fatigue
D003221	Confusion
D008569	Memory Disorders

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012450	Safflower Oil

Ancestor Terms

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

Browse Leaves

Not provided

Browse Branches

Not provided