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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how certain oils might alleviate brain fog in individuals who have had COVID-19. Participants will take either medium-chain triglyceride oil (MCT Oil) or safflower oil daily to assess improvements in cognitive issues. The trial is open to individuals aged 22-50 who had COVID at least three months ago and continue to experience brain fog. The goal is to understand how these supplements might affect brain fog and track its natural progression over time. As an unphased trial, this study provides a unique opportunity to contribute to understanding potential new treatments for brain fog.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Medium Chain Triglyceride (MCT) oil is usually safe for people. Studies have found that individuals with mild memory problems and conditions like seizures can use MCT oil safely. Participants in these studies did not report any serious side effects, though some experienced mild stomach issues, such as cramps or diarrhea.

This trial includes two groups: one will take MCT oil, and the other will take safflower oil. Safflower oil, often used in cooking, is generally safe, with only rare reports of minor stomach issues. Both oils are considered safe, offering a low-risk option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for post-COVID brain fog, which often include cognitive therapy and medications to manage symptoms, Medium Chain Triglyceride (MCT) oil offers a unique approach. MCT oil is derived from coconut or palm oil and is known for providing a rapid source of energy for the brain, potentially improving cognitive function more quickly. Additionally, this treatment is delivered as an oil, making it easy to incorporate into daily nutritional habits. Researchers are excited because MCT oil may offer a more natural and accessible way to alleviate brain fog symptoms, with the potential for faster results compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for post-COVID brain fog?

Research suggests that Medium Chain Triglyceride (MCT) oil, which participants in this trial may receive, could improve brain energy use in individuals experiencing brain fog after COVID-19. MCT oil produces ketones, which the brain can use for energy when it struggles to use glucose. Studies have shown that MCT oil can enhance thinking and memory in people with mild memory issues, suggesting it might also benefit those with brain fog related to long-COVID. In this trial, another group will receive safflower oil as a placebo comparator. Less evidence exists about safflower oil for this purpose, so the focus remains on the potential benefits of MCT oil. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10320593/

Refueling the post COVID-19 brain: potential role of ketogenic ... Ketosis induced by MCT oil supplementation will improve brain energy metabolism post-COVID-19 because ketone bodies will correct/bypass persistent brain glucose ...

2. withpower.com withpower.com/trial/phase-neurobehavioral-manifestations-2-2023-afe1f

Nutritional Supplements 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 ...

3. researchgate.net researchgate.net/publication/371766216_Refueling_the_post_COVID-19_brain_potential_role_of_ketogenic_medium_chain_triglyceride_supplementation_an_hypothesis

(PDF) Refueling the post COVID-19 brain: potential role of ... We notice that the potential benefits of ketogenic medium-chain triglyceride (MCT) supplementation have been similarly proposed both in epilepsy ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37415915/

Refueling the post COVID-19 brain: potential role of ... We hypothesize that cerebral glucose hypometabolism associated with post COVID-19 infection can be mitigated with MCT supplementation, with the prediction that ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952327820301940

The effect of a 6-month ketogenic medium-chain ... Ketogenic medium-chain triglycerides (kMCT) have been shown to improve cognition in mild cognitive impairment. · The long-term effect of kMCT on cardiometabolic ...

6. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03603-5

A randomized feasibility trial of medium chain triglyceride ... An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease.

7. cell.com cell.com/heliyon/fulltext/S2405-8440(23)00653-9

and long-term cognitive and metabolic effects of medium ... Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01669200

Effect of Medium Chain Triglyceride Oil Supplementation in ... The primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (MCI) will improve ...