Nutritional Supplements for Post-COVID Brain Fog
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Unconfirmed COVID, Non-English speakers, others
Trial Summary
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.
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.
12345Is 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.
16789How 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.
1251011Eligibility 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
Unable to speak English
I had memory or thinking problems before COVID.
You do not have a confirmed COVID infection from a PCR or Rapid test.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Medium chain triglyceride oil 15ml tid x 5 months
Group II: PlaceboPlacebo Group1 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:
馃嚭馃嚫 Approved in United States as MCT Oil for:
- Dietary supplement
- Nutritional support
馃嚜馃嚭 Approved in European Union as Medium Chain Triglycerides for:
- Dietary supplement
- Nutritional support
馃嚚馃嚘 Approved in Canada as MCT Oil for:
- Dietary supplement
- Nutritional support
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
Loading ...
Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Refueling the post COVID-19 brain: potential role of ketogenic medium chain triglyceride supplementation: an hypothesis. [2023]COVID-19 infection causes cognitive changes in the acute phase, but also after apparent recovery. Over fifty post (long)-COVID symptoms are described, including cognitive dysfunction ("brain fog") precluding return to pre-COVID level of function, with rates twice as high in females. Additionally, the predominant demographic affected by these symptoms is younger and still in the workforce. Lack of ability to work, even for six months, has significant socio-economic consequences. This cognitive dysfunction is associated with impaired cerebral glucose metabolism, assessed using 18F-fluorodeoxyglucose-positron emission tomography (FDG-PET), showing brain regions that are abnormal compared to age and sex matched controls. In other cognitive conditions such as Alzheimer's disease (AD), typical patterns of cerebral glucose hypometabolism, frontal hypometabolism and cerebellar hypermetabolism are common. Similar FDG-PET changes have also been observed in post-COVID-19, raising the possibility of a similar etiology. Ketone bodies (B-hydroxybutyrate, acetoacetate and acetone) are produced endogenously with very low carbohydrate intake or fasting. They improve brain energy metabolism in the face of cerebral glucose hypometabolism in other conditions [mild cognitive impairment (MCI) and AD]. Long-term low carbohydrate intake or prolonged fasting is not usually feasible. Medium chain triglyceride (MCT) is an exogenous route to nutritional ketosis. Research has supported their efficacy in managing intractable seizures, and cognitive impairment in MCI and AD. We hypothesize that cerebral glucose hypometabolism associated with post COVID-19 infection can be mitigated with MCT supplementation, with the prediction that cognitive function would also improve. Although there is some suggestion that post COVID-19 cognitive symptoms may diminish over time, in many individuals this may take more than six months. If MCT supplementation is able to speed the cognitive recovery, this will impact importantly on quality of life. MCT is readily available and, compared to pharmaceutical interventions, is cost-effective. Research shows general tolerability with dose titration. MCT is a component of enteral and parenteral nutrition supplements, including in pediatrics, so has a long record of safety in vulnerable populations. It is not associated with weight gain or adverse changes in lipid profiles. This hypothesis serves to encourage the development of clinical trials evaluating the impact of MCT supplementation on the duration and severity of post COVID-19 cognitive symptoms.
Serum ferritin level during hospitalization is associated with Brain Fog after COVID-19. [2023]The coronavirus disease 2019 (COVID-19) remains an epidemic worldwide. Most patients suffer residual symptoms, the so-called "Long COVID," which includes respiratory and neuropsychiatric symptoms. Brain Fog, one of the symptoms of Long COVID, is a major public health issue because it can impair patients' quality of life even after recovery from the disease. However, neither the pathogenesis nor the treatment of this condition remains unknown. We focused on serum ferritin levels in this study and collected information on the onset of Brain Fog through questionnaires and found that high ferritin levels during hospitalization were associated with the occurrence of Brain Fog. In addition, we excluded confounders as far as possible using propensity score analyses and found that ferritin was independently associated with Brain Fog in most of the models. We conducted phase analysis and evaluated the interaction of each phase with ferritin levels and Brain Fog. We found a positive correlation between serum ferritin levels during hospitalization and Brain Fog after COVID-19. High ferritin levels in patients with Brain Fog may reflect the contribution of chronic inflammation in the development of Brain Fog. This study provides a novel insight into the pathogenic mechanism of Brain Fog after COVID-19.
Long-Lasting COVID-Associated Brain Fog: A Follow-Up Study. [2023]We investigated the longevity of COVID-associated brain fog in patients who have survived the COVID-19.
Omega-3 Fatty Acid Supplementation for the Treatment of Persistent COVID-Related Olfactory Dysfunction. [2023]To evaluate the efficacy of omega-3 fatty acid (O3FA) supplementation in the treatment of COVID-related olfactory dysfunction (OD).
Multidisciplinary Approach to Brain Fog and Related Persisting Symptoms Post COVID-19. [2022]A third of patients who developed COVID-19 experience a persisting, diverse array of symptoms including respiratory, neurological, and psychiatric complaints referred to as post-acute sequelae of COVID-19 (PASC). Symptoms can last for months after the original infection and appear unrelated to the severity of the initial illness, which suggests that even patients who did not require extensive interventions at the acute stage may experience new and/or long-term symptoms. Brain fog is a colloquial term for a common complaint among patients with PASC and generally implies cognitive impairment in domains of attention and processing speed. There are multiple hypotheses for etiologies and explanations of mechanisms contributing to brain fog in PASC. In this paper, we describe some of the mechanisms associated with brain fog post COVID-19 and provide readers with treatment recommendations that encompass cognition, mood disorders, sleep disorders, and neuroinflammation.
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]Cerebral glucose and insulin metabolism is impaired in Alzheimer's disease (AD). Ketones provide alternative energy. Will medium chain triglyceride (MCT) oil, a nutritional source of ketones, impact cognition in AD?
Assessing the Impact of Factors that Influence the Ketogenic Response to Varying Doses of Medium Chain Triglyceride (MCT) Oil. [2021]Objectives, Design, Setting: The ketogenic effect of medium chain triglyceride (MCT) oil offers potential for Alzheimer's disease prevention and treatment. Limited literature suggests a linear B-hyroxybutyrate (BHB) response to increasing MCT doses. This pharmacokinetic study evaluates factors affecting BHB response in three subject groups.
Short- and long-term cognitive and metabolic effects of medium-chain triglyceride supplementation in rats. [2023]Medium-chain triglycerides (MCT) possess neuroprotective properties. However, the long-term metabolic consequences of supplementing a regular diet with cognition-enhancing doses of MCT are largely unknown. We studied the effects of chronic (28 days) supplementation of regular diet with different doses of MCT oil (1, 3, or 6 g/kg/day) or water (control) on working memory (Y-maze), behavior in the Open Field, spatial learning (Morris water maze), and weight of internal organs in male Wistar 2.5-m.o. Rats. In a separate experiment, we evaluated acute (single gavage) and chronic (28 days) effects of MCT or lard supplementation (3 g/kg) on blood biochemical parameters. MCT-1 and MCT-3 doses improved working memory in YM. In MWM, MCT-6 treatment improved spatial memory. Chronic MCT-1 or MCT-3 treatment did not affect internal organ weight, while MCT-6 dose increased liver weight and the brown/white adipose tissue ratio. Acutely, MCT administration elevated blood 尾-hydroxybutyrate and malondialdehyde levels. Chronic MCT administration (3 g/kg) did not affect the blood levels of glucose, lactate, pyruvate, acetoacetate, 尾-hydroxybutyrate, total and HDL cholesterol, triglycerides, malondialdehyde, and aspartate transaminase and alanine transaminase activities. Therefore, daily supplementation of standard feed with MCT resulted in mild intermittent ketosis. It improved working memory at lower concentrations without significant adverse side effects. At higher concentrations, it improved long-term spatial memory but also resulted in organ weight changes and is likely unsafe. These results highlight the importance of monitoring the metabolic effects of MCT supplementation alongside cognitive assessment in future studies of MCT's neuroprotective properties.
Impact of medium-chain triglycerides on gait performance and brain metabolic network in healthy older adults: a double-blind, randomized controlled study. [2022]Nutritional supplementation with medium-chain triglycerides (MCTs) has the potential to increase memory function in elderly patients with frailty and dementia. Our aim was to investigate the effects of MCT on cognitive and gait functions and their relationships with focal brain metabolism and functional connectivity even in healthy older adults. Participants were blindly randomized and allocated to two groups: 18 g/day of MCT oil and matching placebo formula (control) administered as a jelly stick (6 g/pack, ingested three times a day). Gait analysis during the 6-m walk test, cognition, brain focal glucose metabolism quantified by 18F-fluorodeocyglucose positron emission tomography, and magnetic resonance imaging-based functional connectivity were assessed before and after a 3-month intervention. Sixty-three healthy, normal adults (females and males) were included. Compared with the control group, the MCT group showed better balance ability, as represented by the lower Lissajous index (23.1 ± 14.4 vs. 31.3 ± 18.9; P < 0.01), although no time × group interaction was observed in cognitive and other gait parameters. Moreover, MCT led to suppressed glucose metabolism in the right sensorimotor cortex compared with the control (P < 0.001), which was related to improved balance (r = 0.37; P = 0.04) along with increased functional connectivity from the ipsilateral cerebellar hemisphere. In conclusion, a 3-month MCT supplementation improves walking balance by suppressing glucose metabolism, which suggests the involvement of the cerebro-cerebellar network. This may reflect, at least in part, the inverse reaction of the ketogenic switch as a beneficial effect of long-term MCT dietary treatment.
Proposal of a food supplement for the management of post-COVID syndrome. [2022]A vast majority of COVID-19 patients experience fatigue, extreme tiredness and symptoms that persist beyond the active phase of the disease. This condition is called post-COVID syndrome. The mechanisms by which the virus causes prolonged illness are still unclear. The aim of this review is to gather information regarding post-COVID syndrome so as to highlight its etiological basis and the nutritional regimes and supplements that can mitigate, alleviate or relieve the associated chronic fatigue, gastrointestinal disorders and continuing inflammatory reactions. Naturally-occurring food supplements, such as acetyl L-carnitine, hydroxytyrosol and vitamins B, C and D hold significant promise in the management of post-COVID syndrome. In this pilot observational study, we evaluated the effect of a food supplement containing hydroxytyrosol, acetyl L-carnitine and vitamins B, C and D in improving perceived fatigue in patients who recovered from COVID-19 but had post-COVID syndrome characterized by chronic fatigue. The results suggest that the food supplement could proceed to clinical trials of its efficacy in aiding the recovery of patients with long COVID.
Randomized clinical trial "olfactory dysfunction after COVID-19: olfactory rehabilitation therapy vs. intervention treatment with Palmitoylethanolamide and Luteolin": preliminary results. [2022]Approximately 30% of patients with confirmed COVID-19 report persistent smell or taste disorders as long-term sequalae of infection. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection is associated with inflammatory changes to the olfactory bulb, and treatments with anti-inflammatory properties are hypothesized to attenuate viral injury and promote recovery of olfaction after infection. Our study investigated the efficacy of a supplement with Palmitoylethanolamide (PEA) and Luteolin to support recovery of olfaction in COVID-19 patients.