Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836402
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-04-25
Brief Title:
Long COVID-19 Syndrome Lifestyle Intervention Study
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Low-Carbohydrate Dietary and Lifestyle Interventions for the Management of Long COVID-19 Syndrome A Prospective and Interventional Randomized Controlled Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 11 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 andor 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
Intervention Dietary intervention with Ketocitra versus control arm no intervention in a 11 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 andor 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
Detailed Description:
Hyperglycemia obesity and diabetes are recognized risk factors for worse outcomes in acute COVID-19 Several studies have proposed that a change in the host metabolic state from a carbohydrate-dependent glycolytic to a fat-dependent ketogenic state is expected to be beneficial in acute Covid-19 The benefits may involve several mechanisms including inhibition of inflammatory cytokine secretion inhibition of the NLRP3 inflammasome anti-inflammatory effects on specific T cell populations altered viral replication increased resistance to mitochondrial stress an improvement in antioxidant defenses augmented autophagy and DNA repair
Many of the proposed beneficial mechanisms are thought to be mediated by the main ketone body produced in the ketogenic state beta-hydroxybutyrate BHB Besides its role as a metabolic energy carrier BHB also has pleiotropic signaling functions and potent anti-inflammatory effects Numerous studies indicate that the ketogenic state is tissue- and organ-protective 12-15 such as in acute kidney injury and cardiac and liver injury
The ketogenic state can be induced by dietary interventions such as intermittent fasting time-restricted feeding and high-fat low-carbohydrate ketogenic diets All of these interventions led to the lowering of blood glucose and insulin levels and increased BHB levels Since the 1920s ketogenic diets have been used to treat epilepsy in children They are effective in blood glucose control and lead to effective fat weight loss in obese individuals Ketogenic diets are increasingly used and studied to rapidly reverse nonalcoholic fatty liver disease and insulin resistance polycystic kidney disease PKD and in the management of severe obesity metabolic diseases migraine cancer and numerous other conditions
Recent research indicates that the hyper-inflammatory responses seen in acute COVID-19 are also a feature of long-COVID Long-COVID is characterized by a varying range of long-standing often disabling symptoms that are persisting or appearing after the initial infection and recovery from acute COVID-19 Common symptoms include fatigue brain fog muscle and chest pain migraines shortness of breath anosmia muscle weakness and cognitive dysfunction Interestingly a study found that 35 of long-COVID patients reported having decreased kidney function at 6 months post-discharge and 13 of patients with normal kidney function during the acute phase presented with decreased eGFR at follow-up 28 Furthermore patients with long-COVID and mast cell activation syndrome MCAS tend to experience virtually identical symptoms As a result the induction of ketosis by fasting or the administration of exogenous BHB has been shown to ameliorate hypersensitivity and mast cell degranulation in a rat model of mast cell activation syndrome MCAS
In this study we will evaluate the effects of nutritional management for patients with long-COVID Nutritional management is aimed at lowering blood glucose levels and raising blood BHB levels The dietary plan will recommend a low-carbohydrate diet including avoiding foods containing sugars and starch while simultaneously increasing the consumption of healthy fats and protein sources The dietary intervention is supported by the consumption of a medical food KetoCitra 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
Many of the proposed beneficial mechanisms are thought to be mediated by the main ketone body produced in the ketogenic state beta-hydroxybutyrate BHB Besides its role as a metabolic energy carrier BHB also has pleiotropic signaling functions and potent anti-inflammatory effects Numerous studies indicate that the ketogenic state is tissue- and organ-protective 12-15 such as in acute kidney injury and cardiac and liver injury
The ketogenic state can be induced by dietary interventions such as intermittent fasting time-restricted feeding and high-fat low-carbohydrate ketogenic diets All of these interventions led to the lowering of blood glucose and insulin levels and increased BHB levels Since the 1920s ketogenic diets have been used to treat epilepsy in children They are effective in blood glucose control and lead to effective fat weight loss in obese individuals Ketogenic diets are increasingly used and studied to rapidly reverse nonalcoholic fatty liver disease and insulin resistance polycystic kidney disease PKD and in the management of severe obesity metabolic diseases migraine cancer and numerous other conditions
Recent research indicates that the hyper-inflammatory responses seen in acute COVID-19 are also a feature of long-COVID Long-COVID is characterized by a varying range of long-standing often disabling symptoms that are persisting or appearing after the initial infection and recovery from acute COVID-19 Common symptoms include fatigue brain fog muscle and chest pain migraines shortness of breath anosmia muscle weakness and cognitive dysfunction Interestingly a study found that 35 of long-COVID patients reported having decreased kidney function at 6 months post-discharge and 13 of patients with normal kidney function during the acute phase presented with decreased eGFR at follow-up 28 Furthermore patients with long-COVID and mast cell activation syndrome MCAS tend to experience virtually identical symptoms As a result the induction of ketosis by fasting or the administration of exogenous BHB has been shown to ameliorate hypersensitivity and mast cell degranulation in a rat model of mast cell activation syndrome MCAS
In this study we will evaluate the effects of nutritional management for patients with long-COVID Nutritional management is aimed at lowering blood glucose levels and raising blood BHB levels The dietary plan will recommend a low-carbohydrate diet including avoiding foods containing sugars and starch while simultaneously increasing the consumption of healthy fats and protein sources The dietary intervention is supported by the consumption of a medical food KetoCitra 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None