Low Carbohydrate Diet for Post-COVID Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 2 4 10 11}

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

You tested positive for COVID-19 at least 2 months before the study starts.

I am 18 years old or older.

I have at least two long COVID symptoms like fatigue or headache.

Exclusion Criteria

You have certain health conditions, such as chronic high potassium levels, HIV, drug or alcohol abuse, malabsorption syndrome, certain types of cancer, autoimmune disease, specific digestive and urinary tract issues, certain types of diabetes, heart and kidney problems, or other conditions that make you unsuitable for the study. You are pregnant, planning to become pregnant, or nursing. You are not willing to make dietary changes, undergo blood tests, or keep track of your health information for the study. You have certain dietary restrictions or allergies, or you rely on oxygen or dialysis treatment.

I am currently in the hospital.

Any significant systemic illness or medical condition or use of medication that could affect the safety of the research subject or could affect compliance with the study, as determined by the study personnel and a physician

Treatment Details

Interventions

• Low carbohydrate diet intervention (Behavioural Intervention)

Trial Overview The trial is testing a low-carbohydrate diet intervention aimed at reducing blood glucose and increasing blood BHB levels to improve long COVID symptoms. This includes avoiding sugars and starches while consuming healthy fats and proteins along with a medical food supplement. The control group will receive standard therapy without dietary changes.

Participant Groups

Group I: Low Carbohydrate Experimental Treatment 1 Intervention

-Low-Carbohydrate Diet Intervention:Patients will receive a study kit. The kit will contain the following: * Instruction sheet containing medical food instructions and food journal and a web link to the weekly online journal * A 30-day supply of the medical food, KetoCitra, developed by Santa Barbara Nutrients, Inc. KetoCitra® is a ready-to-mix powder to be dissolved in water and taken twice per day with meals. KetoCitra® contains BHB, citrate, and a blend of minerals (potassium, calcium, magnesium) and is flavored with natural lemon flavor and stevia natural sweetener. KetoCitra® is sugar- and sodium-free and is intended to support the metabolic switch aimed for with the low-carbohydrate diet by providing exogenous BHB. (Package insert)

Group II: Control Active Control 1 Intervention

-Usual diet.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Keck School of Medicine of USC Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

References

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

Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. [2022] With the increase in total coronavirus disease 2019 (COVID-19) infection cases, post-acute COVID-19 syndrome, defined as experiencing ongoing health problems 4 or more weeks after the first severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has become a new arising public health concern. As part of post-acute COVID-19 syndrome, gastrointestinal symptoms might be associated with dysbiosis of the gut microbiota, which has the potential to become a target for intervention. In this study, a patient with post-acute COVID-19 syndrome with long-lasting severe gastrointestinal symptoms was provided 2-month expanded access to a high-fiber formula with investigational new drug (IND) status developed to alleviate COVID-19-related symptoms by modulating the gut microbiota. Symptoms including severe "loss of appetite," palpitation, and anxiety were significantly alleviated by the end of the intervention. The medication dosage for controlling nausea decreased during the intervention. The serum lipid profile, insulin level, and leptin level were improved compared to the baseline values. Significant structural changes of the patient's gut microbiota and reduced microbial fermentation activity in the small intestine were found during the intervention. Eighteen amplicon sequence variants (ASVs) of the V4 region of the 16S rRNA gene significantly responded to this nutritional intervention. Six out of the 18 ASVs were also found to be negatively correlated with symptom severity/medication dosage. Five of the six ASVs (ASV0AKS_Oscillibacter, ASV009F_Anaerofustis, ASV02YT_Blautia, ASV07LA_Blautia, and ASV0AM6_Eubacterium hallii) were potential short-chain fatty acid (SCFA)-producing bacteria, which might be associated with the alleviation of symptoms. Our study indicates the feasibility of alleviating gastrointestinal symptoms in patients with post-acute COVID-19 syndrome by way of nutritional modulation of their gut microbiota. IMPORTANCE It has become evident that the care of patients with COVID-19 does not end at the time of negative SARS-CoV-2 detection, as the number of patients with post-acute COVID-19 syndrome increases with an ever-increasing total infected patient population. This case report shows the possibility of alleviating the gastrointestinal symptoms of post-acute COVID-19 syndrome via microbiota-targeted nutritional intervention. As a promising strategy, it might not only improve the quality of life of patients but also reduce the burden to the public health system when the end of the COVID-19 pandemic is not in sight.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of COVID-19 Infection and Persistent Lingering Symptoms on Patient Reported Indicators of Nutritional Risk and Malnutrition. [2022] Persistent malnutrition after COVID-19 infection may worsen outcomes, including delayed recovery and increased risk of rehospitalization. This study aimed to determine dietary intakes and nutrient distribution patterns after acute COVID-19 illness. Findings were also compared to national standards for intake of energy, protein, fruit, and vegetables, as well as protein intake distribution recommendations. Participants (≥18 years old, n = 92) were enrolled after baseline visit at the Post-COVID Recovery Clinic. The broad screening battery included nutritional assessment and 24-h dietary recall. Participants were, on average, 53 years old, 63% female, 69% non-Hispanic White, and 59% obese/morbidly obese. Participants at risk for malnutrition (48%) experienced significantly greater symptoms, such as gastric intestinal issues, loss of smell, loss of taste, or shortness of breath; in addition, they consumed significantly fewer calories. Most participants did not meet recommendations for fruit or vegetables. Less than 39% met the 1.2 g/kg/day proposed optimal protein intake for recovery from illness. Protein distribution throughout the day was skewed; only 3% met the recommendation at all meals, while over 30% never met the threshold at any meal. Our findings highlight the need for nutritional education and support for patients to account for lingering symptoms and optimize recovery after COVID-19 infection.

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

Ketogenic Diet and Ketone Bodies as Clinical Support for the Treatment of SARS-CoV-2-Review of the Evidence. [2023] One of the proposed nutritional therapies to support drug therapy in COVID-19 is the use of a ketogenic diet (KD) or ketone bodies. In this review, we summarized the evidence from tissue, animal, and human models and looked at the mechanisms of action of KD/ketone bodies against COVID-19. KD/ketone bodies were shown to be effective at the stage of virus entry into the host cell. The use of β-hydroxybutyrate (BHB), by preventing the metabolic reprogramming associated with COVID-19 infection and improving mitochondrial function, reduced glycolysis in CD4+ lymphocytes and improved respiratory chain function, and could provide an alternative carbon source for oxidative phosphorylation (OXPHOS). Through multiple mechanisms, the use of KD/ketone bodies supported the host immune response. In animal models, KD resulted in protection against weight loss and hypoxemia, faster recovery, reduced lung injury, and resulted in better survival of young mice. In humans, KD increased survival, reduced the need for hospitalization for COVID-19, and showed a protective role against metabolic abnormalities after COVID-19. It appears that the use of KD and ketone bodies may be considered as a clinical nutritional intervention to assist in the treatment of COVID-19, despite the fact that numerous studies indicate that SARS-CoV-2 infection alone may induce ketoacidosis. However, the use of such an intervention requires strong scientific validation.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Recommendations for Post-COVID-19 Syndrome. [2022] At the beginning of the coronavirus disease (COVID-19) pandemic, global efforts focused on containing the spread of the virus and avoiding contagion. Currently, it is evident that health professionals should deal with the overall health status of COVID-19 survivors. Indeed, novel findings have identified post-COVID-19 syndrome, which is characterized by malnutrition, loss of fat-free mass, and low-grade inflammation. In addition, the recovery might be complicated by persistent functional impairment (i.e., fatigue and muscle weakness, dysphagia, appetite loss, and taste/smell alterations) as well as psychological distress. Therefore, the appropriate evaluation of nutritional status (assessment of dietary intake, anthropometrics, and body composition) is one of the pillars in the management of these patients. On the other hand, personalized dietary recommendations represent the best strategy to ensure recovery. Therefore, this review aimed to collect available evidence on the role of nutrients and their supplementation in post-COVID-19 syndrome to provide a practical guideline to nutritionists to tailor dietary interventions for patients recovering from COVID-19 infections.

5. England pubmed.ncbi.nlm.nih.gov

The dark side of the spoon - glucose, ketones and COVID-19: a possible role for ketogenic diet? [2020] The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. Notably, obesity and its related comorbidities are strictly related with worse clinical outcomes of COVID-19 disease. Recently, there is a growing interest in the clinical use of ketogenic diets (KDs), particularly in the context of severe obesity with related metabolic complications. KDs have been proven effective for a rapid reduction of fat mass, preserving lean mass and providing an adequate nutritional status. In particular, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to prevent infection and potential adverse outcomes of COVID-19 disease. We discuss here the importance of KDs for a rapid reduction of several critical risk factors for COVID-19, such as obesity, type 2 diabetes and hypertension, based on the known effects of ketone bodies on inflammation, immunity, metabolic profile and cardiovascular function. We do believe that a rapid reduction of all modifiable risk factors, especially obesity with its metabolic complications, should be a pillar of public health policies and interventions, in view of future waves of SARS-CoV-2 infection.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of the COVID-19 Pandemic on the Effectiveness of a Metabolic Health Telemedicine Intervention for Weight Loss: A Propensity Score Matching Analysis. [2022] Coronavirus disease 2019 (COVID-19) pandemic public health measures such as stay-at-home and mandatory work-from-home orders have been associated with obesogenic lifestyle changes, increased risk of weight gain, and their metabolic sequelae. We sought to assess the impact of this pandemic on weight loss from a telemedicine-delivered very-low-carbohydrate intervention targeting nutritional ketosis (NKI).

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

The ketogenic diet for intractable epilepsy in adults: preliminary results. [2019] Little is known concerning the efficacy and adverse effects of the ketogenic diet in adults with refractory epilepsy. This review reports preliminary results in 11 adults prospectively treated with the diet who had previously failed to gain seizure control with two or more medications and/or surgery.

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

A ketogenic diet can mitigate SARS-CoV-2 induced systemic reprogramming and inflammation. [2023] The ketogenic diet (KD) has demonstrated benefits in numerous clinical studies and animal models of disease in modulating the immune response and promoting a systemic anti-inflammatory state. Here we investigate the effects of a KD on systemic toxicity in mice following SARS-CoV-2 infection. Our data indicate that under KD, SARS-CoV-2 reduces weight loss with overall improved animal survival. Muted multi-organ transcriptional reprogramming and metabolism rewiring suggest that a KD initiates and mitigates systemic changes induced by the virus. We observed reduced metalloproteases and increased inflammatory homeostatic protein transcription in the heart, with decreased serum pro-inflammatory cytokines (i.e., TNF-α, IL-15, IL-22, G-CSF, M-CSF, MCP-1), metabolic markers of inflammation (i.e., kynurenine/tryptophane ratio), and inflammatory prostaglandins, indicative of reduced systemic inflammation in animals infected under a KD. Taken together, these data suggest that a KD can alter the transcriptional and metabolic response in animals following SARS-CoV-2 infection with improved mice health, reduced inflammation, and restored amino acid, nucleotide, lipid, and energy currency metabolism.

9. England pubmed.ncbi.nlm.nih.gov

Reduced COVID-19 severity elicited by weight loss from a medically supervised ketogenic diet in a geographically diverse ambulatory population with type 2 diabetes and obesity. [2023] To investigate factors associated with COVID-19 severity in ambulatory individuals with type 2 diabetes mellitus (T2DM) and obesity treated with a medically supervised ketogenic diet (MSKD).

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of micronutrients in the comprehensive rehabilitation of patients with the novel coronavirus infection COVID-19]. [2021] Post-COVID disorders syndrome (PCDS) is an umbrella term for a complex of persistent symptoms that a patient can develop after suffering from COVID-19. The aim of the research was to systematize data on the role of micronutrients in the treatment of PCDS. Material and methods. The authors carried out a systematic analysis of foreign (ncbi. nlm.nih.gov) and Russian (elibrary.ru) scientific publications. Results. The most common symptoms that can persist for a long time after a coronavirus infection can be divided into 4 groups: 1) hypoxic syndrome (respiratory and oxygen deficiency); 2) asthenic syndrome; 3) syndrome of neuropsychiatric disorders; 4) gastrointestinal symptoms. Adequate dietary intake of vitamins and mineral substances is critical for the proper functioning of the immune system and maintenance of the organism functional reserves. The optimal consumption of vitamins D, C and E, zinc and ω-3 fatty acids with ration can be useful for preventing infection, supporting immunity during COVID-19 disease and in the complex of rehabilitation of patients with PCDS. Conclusion. Intake of dietary supplements containing complex of micronutrients can be recommended as a rational adjuvant therapy during the rehabilitation period after COVID-19. However, further research is essential to determine the effective dosage of vitamins and other micronutrients to reduce the manifestations of PCDS.

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

A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. [2023] Post-acute COVID-19 syndrome (PACS) affects over 65 million individuals worldwide but treatment options are scarce. We aimed to assess a synbiotic preparation (SIM01) for the alleviation of PACS symptoms.