Nutritional Supplements for Post-COVID Brain Fog

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Unconfirmed COVID, Non-English speakers, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that any other medical conditions are stable and that you are on stable doses of medications if needed.

What data supports the effectiveness of the treatment Medium Chain Triglyceride Oil for post-COVID brain fog?

Research suggests that Medium Chain Triglyceride (MCT) oil may help improve brain energy metabolism in conditions with impaired glucose metabolism, like Alzheimer's disease, and could potentially aid cognitive recovery in post-COVID brain fog by providing an alternative energy source for the brain. ^{1 2 3 4 5}

Is MCT oil safe for human use?

MCT oil is generally considered safe for human use, with research showing it is well-tolerated and not associated with weight gain or negative changes in blood lipid levels. It has a long record of safety, even in vulnerable populations like children, and is used in various nutritional supplements. ^{1 6 7 8 9}

How does the treatment with Medium Chain Triglyceride Oil differ from other treatments for post-COVID brain fog?

This treatment is unique because it uses Medium Chain Triglyceride (MCT) Oil to improve brain energy metabolism by providing an alternative energy source (ketone bodies) for the brain, which may be impaired in processing glucose after COVID-19. Unlike other treatments, MCT Oil is a nutritional supplement that is cost-effective, generally well-tolerated, and has a long record of safety, making it a novel approach compared to pharmaceutical interventions. ^{1 2 5 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals aged 22-50 who had a confirmed COVID infection at least 3 months ago and are experiencing ongoing 'brain fog'. They must have stable medical conditions and, if taking medications, be on stable doses. People cannot join if they can't speak English, didn't confirm their COVID with a test, or had cognitive issues before COVID.

Inclusion Criteria

I had COVID-19 over 3 months ago and still have thinking or memory problems.

My health conditions are stable and my medications haven't changed recently.

Exclusion Criteria

I had memory or thinking problems before COVID.

You do not have a confirmed COVID infection from a PCR or Rapid test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either safflower oil or medium chain triglyceride oil daily for 5 months

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Treatment Details

Interventions

• Medium Chain Triglyceride Oil
• Nutritional Management
• Safflower Oil

Trial Overview The study is testing the effects of two dietary oils - medium chain triglyceride oil and safflower oil - on post-COVID 'brain fog'. Participants will consume one type of oil daily and undergo brain function tests to see if there's any improvement in their symptoms.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Medium chain triglyceride oil 15ml tid x 5 months

Group II: Placebo Placebo Group 1 Intervention

Safflower oil 15mls tid x 5 months

Medium Chain Triglyceride Oil is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MCT Oil for:

• Dietary supplement
• Nutritional support

Approved in European Union as Medium Chain Triglycerides for:

• Dietary supplement
• Nutritional support

Approved in Canada as MCT Oil for:

• Dietary supplement
• Nutritional support

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

Post-COVID-19 cognitive dysfunction, often referred to as 'brain fog', affects many individuals, particularly younger females, and is linked to impaired brain glucose metabolism, similar to patterns seen in Alzheimer's disease.

Medium chain triglyceride (MCT) supplementation may help improve cognitive function in individuals experiencing post-COVID-19 cognitive symptoms by addressing cerebral glucose hypometabolism, and it has a strong safety profile and cost-effectiveness compared to traditional pharmaceuticals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refueling the post COVID-19 brain: potential role of ketogenic medium chain triglyceride supplementation: an hypothesis. Juby, AG., Cunnane, SC., Mager, DR.[2023]

High serum ferritin levels during hospitalization for COVID-19 are associated with the development of Brain Fog, a significant residual symptom affecting quality of life post-recovery.

The study suggests that elevated ferritin may indicate chronic inflammation contributing to Brain Fog, providing new insights into its underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum ferritin level during hospitalization is associated with Brain Fog after COVID-19. Ishikura, T., Nakano, T., Kitano, T., et al.[2023]

In a follow-up study of 1,164 COVID-19 survivors, 2.2% reported long-lasting brain fog symptoms over 11 months after their initial illness, indicating that cognitive difficulties can persist long after recovery.

Patients who experienced long-lasting brain fog were more likely to have had severe cases of COVID-19, with a higher rate of ICU admissions (23.1% vs. 9.3%), suggesting a link between the severity of the initial illness and cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Lasting COVID-Associated Brain Fog: A Follow-Up Study. Asadi-Pooya, AA., Shahisavandi, M., Nemati, H., et al.[2023]

In a study of 117 patients with COVID-related olfactory dysfunction, omega-3 fatty acid (O3FA) supplementation did not show a significant improvement in smell identification scores compared to a placebo after 6 weeks.

Long-term follow-up also revealed no meaningful difference in olfactory recovery between the O3FA group and the placebo group, suggesting that high doses of O3FA may not be effective for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acid Supplementation for the Treatment of Persistent COVID-Related Olfactory Dysfunction. Lerner, DK., Garvey, KL., Arrighi-Allisan, A., et al.[2023]

About one-third of COVID-19 patients experience long-lasting symptoms, known as post-acute sequelae of COVID-19 (PASC), which can include respiratory, neurological, and psychiatric issues, regardless of the severity of their initial illness.

'Brain fog,' a common symptom of PASC characterized by cognitive impairment, may be linked to various mechanisms such as neuroinflammation, and the paper offers treatment recommendations addressing cognitive and mood disorders, sleep issues, and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Approach to Brain Fog and Related Persisting Symptoms Post COVID-19. Krishnan, K., Lin, Y., Prewitt, KM., et al.[2022]

In a 6-month randomized, double-blind, placebo-controlled study involving 20 participants with probable Alzheimer's disease, 80% of subjects showed stabilization or improvement in cognitive function after consuming medium chain triglyceride (MCT) oil, suggesting its potential as a beneficial nutritional intervention.

Longer exposure to MCT oil and participants older than 73 years were associated with significantly better cognitive outcomes, as measured by the Mini-Mental State Examination (MMSE), indicating that age and duration of treatment may enhance the efficacy of MCT oil in improving cognition in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of medium chain triglyceride (MCT) oil in subjects with Alzheimer's disease: A randomized, double-blind, placebo-controlled, crossover study, with an open-label extension. Juby, AG., Blackburn, TE., Mager, DR.[2022]

The study evaluated the effects of different doses of medium chain triglyceride (MCT) oil on blood levels of beta-hydroxybutyrate (BHB) in 25 participants, including healthy individuals and those with Alzheimer's disease, showing a linear dose-response relationship for BHB levels.

Significant individual variability was observed in BHB response to MCT oil, influenced by factors such as body composition and pre-test meal content, indicating that personal characteristics may affect the efficacy of MCT oil as a treatment for Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Impact of Factors that Influence the Ketogenic Response to Varying Doses of Medium Chain Triglyceride (MCT) Oil. Juby, AG., Brocks, DR., Jay, DA., et al.[2021]

Chronic supplementation of a regular diet with medium-chain triglycerides (MCT) for 28 days improved working memory in rats at lower doses (1 and 3 g/kg/day) without significant adverse effects on internal organ weight.

However, at a higher dose (6 g/kg/day), MCT enhanced long-term spatial memory but also led to increased liver weight and changes in fat tissue ratios, suggesting potential safety concerns that warrant further monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term cognitive and metabolic effects of medium-chain triglyceride supplementation in rats. Shcherbakova, K., Schwarz, A., Ivleva, I., et al.[2023]

In a study of 63 healthy older adults, supplementation with 18g/day of medium-chain triglycerides (MCTs) for 3 months significantly improved balance, as indicated by a lower Lissajous index, compared to a placebo group.

MCT supplementation was associated with reduced glucose metabolism in the right sensorimotor cortex, which correlated with improved balance, suggesting that MCTs may enhance walking stability through effects on brain metabolism and functional connectivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of medium-chain triglycerides on gait performance and brain metabolic network in healthy older adults: a double-blind, randomized controlled study. Mutoh, T., Kunitoki, K., Tatewaki, Y., et al.[2022]

A pilot observational study suggests that a food supplement containing hydroxytyrosol, acetyl L-carnitine, and vitamins B, C, and D may help improve perceived fatigue in patients suffering from post-COVID syndrome after recovering from COVID-19.

The findings indicate that this supplement could be a promising intervention for alleviating chronic fatigue and other symptoms associated with long COVID, warranting further clinical trials to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal of a food supplement for the management of post-COVID syndrome. Naureen, Z., Dautaj, A., Nodari, S., et al.[2022]

In a pilot study of 12 COVID-19 patients with persistent smell disorders, those who received a daily oral supplement of Palmitoylethanolamide (PEA) and Luteolin alongside olfactory rehabilitation showed significant improvement in their sense of smell compared to the control group.

The study suggests that combining olfactory rehabilitation with PEA and Luteolin may enhance recovery of olfactory function, especially in patients with long-term smell issues, indicating a potential therapeutic approach for post-COVID-19 olfactory impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial "olfactory dysfunction after COVID-19: olfactory rehabilitation therapy vs. intervention treatment with Palmitoylethanolamide and Luteolin": preliminary results. D'Ascanio, L., Vitelli, F., Cingolani, C., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Refueling the post COVID-19 brain: potential role of ketogenic medium chain triglyceride supplementation: an hypothesis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Serum ferritin level during hospitalization is associated with Brain Fog after COVID-19. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Lasting COVID-Associated Brain Fog: A Follow-Up Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Omega-3 Fatty Acid Supplementation for the Treatment of Persistent COVID-Related Olfactory Dysfunction. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Multidisciplinary Approach to Brain Fog and Related Persisting Symptoms Post COVID-19. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use of medium chain triglyceride (MCT) oil in subjects with Alzheimer's disease: A randomized, double-blind, placebo-controlled, crossover study, with an open-label extension. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Impact of Factors that Influence the Ketogenic Response to Varying Doses of Medium Chain Triglyceride (MCT) Oil. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Short- and long-term cognitive and metabolic effects of medium-chain triglyceride supplementation in rats. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of medium-chain triglycerides on gait performance and brain metabolic network in healthy older adults: a double-blind, randomized controlled study. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Proposal of a food supplement for the management of post-COVID syndrome. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Randomized clinical trial "olfactory dysfunction after COVID-19: olfactory rehabilitation therapy vs. intervention treatment with Palmitoylethanolamide and Luteolin": preliminary results. [2022]