Low Carbohydrate Diet for Post-COVID Syndrome
Trial Summary
What is the purpose of this trial?
Rationale: Hyper-inflammatory responses seen in acute COVID-19 are also a feature of long covid, a condition of long-term consequences that are persisting or appearing after initial infection and recovery from acute COVID-19. Long-standing, often disabling symptoms are common in long covid and can be highly varied. Common symptoms include fatigue, brain fog, muscle and chest pain, migraines, shortness of breath, anosmia, muscle weakness, and cognitive dysfunction. 35% of post-COVID patients were found to have decreased kidney function at 6 months post-discharge. In this study, we will evaluate the effect of dietary interventions in long covid patients. The dietary interventions are aimed at lowering blood glucose levels, and raising blood BHB levels. The dietary plan will recommend a low-carbohydrate diet including the avoidance of foods containing sugars and starch, while simultaneously increasing the consumption of healthy fats and sources of protein. The dietary interventions are supported by the consumption of a medical food that delivers exogenous BHB in order to raise blood BHB levels without the necessity of adhering to a strict ketogenic diet which would be difficult to implement and typically requires strict medical supervision. Intervention: Dietary intervention with Ketocitra versus control arm (no intervention) in a 1:1 ratio Objectives: The hypothesis of this study is that low-carbohydrate dietary interventions leading to lowering of blood glucose and raising of blood BHB in addition to standard therapy will lead to faster recovery and amelioration of symptoms in long covid compared to those treated with standard therapy alone. Study population: Subjects with a history of COVID-19 at least 2 months ago and with at least 2 neurological and/or symptoms that are typical for long covid that either started at COVID-19 infection and are ongoing at time of study entry Study methodology: Prospective and interventional randomized controlled pilot study Study arms: Dietary intervention (including medical food) arm versus control arm Study endpoints: The primary endpoint is the feasibility, safety and tolerability of dietary intervention.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are using certain medications like KetoCitra, urine alkalizing agents, citrate treatments, calcium supplements, antacids or phosphate binders containing aluminum, SGLT2 inhibitors, or immunosuppressive treatments. It's best to discuss your current medications with the study personnel to see if they affect your eligibility.
What data supports the idea that Low Carbohydrate Diet for Post-COVID Syndrome is an effective treatment?
The available research shows that a ketogenic diet, which is a type of low carbohydrate diet, may help in the treatment of COVID-19 by supporting the immune system and improving recovery. In humans, it has been associated with increased survival rates and reduced need for hospitalization. Additionally, it may help manage metabolic issues that arise after COVID-19. While the research is promising, it suggests that more scientific validation is needed to confirm these benefits.12345
What safety data exists for low-carb diets in treating post-COVID syndrome?
The safety data for low-carb diets, including ketogenic diets, in the context of post-COVID syndrome is limited but promising. Research suggests that ketogenic diets can reduce inflammation and improve metabolic health, which may benefit COVID-19 patients, especially those with obesity and type 2 diabetes. Studies have shown that ketogenic diets can lead to weight loss and reduced COVID-19 severity in these populations. However, most of the data comes from studies on obesity, diabetes, and other conditions, rather than direct studies on post-COVID syndrome. More research is needed to fully understand the safety and efficacy of these diets specifically for post-COVID syndrome.56789
Is the low carbohydrate diet a promising treatment for post-COVID syndrome?
Yes, a low carbohydrate diet, which includes options like the ketogenic diet, can be a promising treatment for post-COVID syndrome. This type of diet may help improve gut health, which is important because post-COVID syndrome can cause digestive issues. By improving gut health, the diet might help reduce symptoms like loss of appetite and anxiety, and improve overall well-being.1241011
Eligibility Criteria
Adults who had COVID-19 at least 2 months ago and are experiencing ongoing neurological or physical symptoms typical of long COVID, such as fatigue, loss of smell, or shortness of breath. Participants must not be hospitalized or have conditions like chronic kidney disease stage III+, heart failure, liver cirrhosis, autoimmune diseases, active infections, certain eating disorders or be on specific medications that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a low-carbohydrate dietary intervention with KetoCitra or follow a usual diet for 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Low carbohydrate diet intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor