Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522750
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-17
Brief Title:
Periodic Fasting for Treatment of Long Covid in Adults a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study on the Feasibility of an RCT Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASTCOV-P
Brief Summary:
Background
Long COVID characterized by persistent symptoms following acute COVID-19 infection has emerged as a significant public health concern Symptoms range from fatigue cognitive impairments to respiratory difficulties affecting patients39 quality of life Dietary interventions particularly fasting have historically been used to modulate immune responses and improve health outcomes in various conditions The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach Given the inflammatory nature of long COVID fasting may offer therapeutic benefits by modulating the immune response enhancing cellular repair mechanisms and resetting metabolic processes
Objectives
This clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective As secondary objectives the study will investigate the potential beneficial impact of fasting on clinical biological and psychological parameters over a period of 4 weeks offering insights into potential therapeutic avenues for long COVID management
Study timeline
The research will span a period of 4 weeks
Study population
This study aims to recruit around 20 participants who will all receive a fasting intervention using the Buchinger-Wilhelmi method
Biological sample and data collection
Participants will undergo various data and sample collection procedures including blood draws of up to 90 42 ml per visit collection of peripheral mononuclear cells stool samples and completion of questionnaires in a smartphone-based Application MyCap
Sample analysis
The collected samples will be subjected to a range of analyses including the assessment of serological markers for routine blood chemistry evaluation of inflammation markers and examination of stool samples
Long COVID characterized by persistent symptoms following acute COVID-19 infection has emerged as a significant public health concern Symptoms range from fatigue cognitive impairments to respiratory difficulties affecting patients39 quality of life Dietary interventions particularly fasting have historically been used to modulate immune responses and improve health outcomes in various conditions The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach Given the inflammatory nature of long COVID fasting may offer therapeutic benefits by modulating the immune response enhancing cellular repair mechanisms and resetting metabolic processes
Objectives
This clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective As secondary objectives the study will investigate the potential beneficial impact of fasting on clinical biological and psychological parameters over a period of 4 weeks offering insights into potential therapeutic avenues for long COVID management
Study timeline
The research will span a period of 4 weeks
Study population
This study aims to recruit around 20 participants who will all receive a fasting intervention using the Buchinger-Wilhelmi method
Biological sample and data collection
Participants will undergo various data and sample collection procedures including blood draws of up to 90 42 ml per visit collection of peripheral mononuclear cells stool samples and completion of questionnaires in a smartphone-based Application MyCap
Sample analysis
The collected samples will be subjected to a range of analyses including the assessment of serological markers for routine blood chemistry evaluation of inflammation markers and examination of stool samples
Detailed Description:
Background Long COVID syndrome LCS is a heterogeneous clinical condition that develops after acute SARS-CoV-2 infection affecting at least 10 of patients LCS is characterized by persistent symptoms lasting longer than 2-3 months following a confirmed SARS-CoV-2 infection The most disruptive symptoms include fatigue shortness of breath pain depressionanxiety and cognitive impairment significantly impacting daily activities income and quality of life
Pathophysiology of LCS
Immunological Dysregulation
Persistent activation of monocyte populations including resident and infiltrating macrophages dendritic cells and neutrophils potentially causing tissue damage
Reservoirs of SARS-CoV-2 may persist particularly in respiratory and gastrointestinal tracts contributing to ongoing lymphocyte activation
Autoimmunity involving T-cells and B-cells has been observed with cytokines such as interferon gamma IL-2 IL-4 IL-6 IL-8 IL-10 and IL-17 frequently implicated
Tissue fibrosis a consequence of inflammation is commonly reported
Vascular Dysfunction and Coagulopathy
Impaired fibrinolysis and platelet hyperactivation contribute to microclot formation entrapping pro-inflammatory molecules like IL-6
Platelet-poor plasma in LCS patients shows high levels of fibrin amyloid microclots impairing microcirculation and exacerbating immunopathology
Aberrant immune cell activity increases thrombosis through autoantibodies and NETosis
Persistent endothelial dysfunction is a common feature contributing to numerous LCS symptoms
Gastrointestinal Involvement
SARS-CoV-2 infection reduces intestinal microbiota diversity with recovery correlating to reduced LCS risk
Specific bacterial taxa such as Escherichia are associated with severe COVID-19 and LCS
Functional dyspepsia and irritable bowel syndrome related to microbial dysbiosis are common post-COVID conditions
Gut microbiota influences LCS-related biological functions particularly psychological symptoms through modulation of brain chemicals and gut-blood barrier disruption
Potential of Fasting as a Treatment for LCS Fasting shows promise as a treatment for LCS by modulating the same cellular systems affected by LCS A recent small study indicated that 92 of LCS patients experienced symptom improvement during long-term fasting with notable effects on circulating inflammatory molecules C-reactive protein levels and dyslipidemia Fasting can increase beneficial gut microbial genera and alter blood metabolites potentially disrupting dysfunctional circuits in LCS
Significance LCS affects over 150 million people worldwide with more than half experiencing significant work and lifestyle disruptions Effective low-cost and attainable therapeutic options are urgently needed Medically supervised fasting particularly intermittent fasting could be an accessible and safe intervention with minimal physician oversight and low malnutrition risk Fasting may also prevent other chronic illnesses associated with LCS such as type 2 diabetes mellitus
Hypothesis Our primary hypothesis is that ambulatory fasting intervention using the Buchinger-Wilhelmi method is a feasible treatment for LCS We propose that medically supervised long-term fasting will improve perceived health and quality of life in LCS patients by disrupting inflammatory immuno-metabolic feed-forward loops thus ameliorating immune and vascular pathologies
Methodology and Analysis Patient Eligibility
Inclusion Criteria
Age 18-64 Diagnosis of LCS post-acute COVID-19 symptoms persisting 12 weeks Normal BMI 185 to 25 kgm² Marginal iron status PF 25 ngml Ability to communicate in and comprehend English German or French Written and signed consent Willingness to consent to specimen collection and use
Exclusion Criteria
BMI 185 kgm² or significant recent weight loss History of eating disorders within the past five years Severe internal disease or chronic inflammatory illness other than LCS Participation in another intervention study Recent fasting or vegan diet Pregnancy or breastfeeding Existing MECFS or early autonomous dysfunction Chronic inflammatory bowel diseases celiac disease or colorectal cancer Use of anti-psychotic drugs or recent antibiotic use Contraindication for additional blood draws Start of novel drug therapy Intervention
The primary goal is to perform a single period of periodic fasting PF using the Buchinger procedure involving an initial bowel cleanse followed by a 7-day fasting period The fasting regimen includes
Preparation Phase Three days of relief with reduced food intake avoiding stimulants
Fasting Week A laxative fluid intake on the first day followed by 7 days of a dietary energy supply of a maximum of 350 kcal per day vegetable broths and juices and consumption of calorie-free water or tea
Support and Guidance Detailed instructions face-to-face consultations and digital application MyCap for adherence confirmation via urine ketone measurements
Sample and Data Collection Sample Size 20 patients for the pilot study to test feasibility
Study Outline
Inclusion visit for risk explanation medical history and physical examination
Daily follow-up via telephone and online appointments during the fasting phase Questionnaire-based assessment via MyCap Smartphone Application
Parameters to be Quantified
Blood samples for safety parameters metabolites immune activity indicators and additional analyses
Stool samples for microbiome composition and activity Urine samples for metabolomics Saliva samples for cortisol measurements Analysis and Results Interpretation Results will be analyzed descriptively with means standard deviations and graphs summarizing data Exploratory analysis will identify patterns trends or unexpected results Correlation with improvement in biomedical parameters will be assessed with a larger study needed for establishing causal links
Risks Blood Draw Discomfort bleeding swelling pain rare nerve damage or infection at the injection site and fainting risk
Periodic Fasting Protocol Reduction in blood pressure closely monitored with non-medical interventions if necessary
Data Collection and Storage Data is collected using REDCap a secure web-based software platform with pseudonymized data stored for at least 10 years post-study The Principal Investigator ensures compliance with national laws and GDPR
Regulatory and Ethical Considerations Informed Consent Participants receive an easily understood Participant Information Sheet and Informed Consent Form with contact information for study personnel
Confidentiality and Privacy Compliance with national laws and GDPR with pseudonymized data transfer to third parties only with participant consent
Financing and Insurance Supported by the Direction de la Santé CHNP and the University of Luxembourg
Conclusion This pilot study aims to test the feasibility of using the Buchinger-Wilhelmi fasting method for treating LCS If successful fasting could provide a low-cost accessible and effective therapeutic option for LCS sufferers worldwide
Pathophysiology of LCS
Immunological Dysregulation
Persistent activation of monocyte populations including resident and infiltrating macrophages dendritic cells and neutrophils potentially causing tissue damage
Reservoirs of SARS-CoV-2 may persist particularly in respiratory and gastrointestinal tracts contributing to ongoing lymphocyte activation
Autoimmunity involving T-cells and B-cells has been observed with cytokines such as interferon gamma IL-2 IL-4 IL-6 IL-8 IL-10 and IL-17 frequently implicated
Tissue fibrosis a consequence of inflammation is commonly reported
Vascular Dysfunction and Coagulopathy
Impaired fibrinolysis and platelet hyperactivation contribute to microclot formation entrapping pro-inflammatory molecules like IL-6
Platelet-poor plasma in LCS patients shows high levels of fibrin amyloid microclots impairing microcirculation and exacerbating immunopathology
Aberrant immune cell activity increases thrombosis through autoantibodies and NETosis
Persistent endothelial dysfunction is a common feature contributing to numerous LCS symptoms
Gastrointestinal Involvement
SARS-CoV-2 infection reduces intestinal microbiota diversity with recovery correlating to reduced LCS risk
Specific bacterial taxa such as Escherichia are associated with severe COVID-19 and LCS
Functional dyspepsia and irritable bowel syndrome related to microbial dysbiosis are common post-COVID conditions
Gut microbiota influences LCS-related biological functions particularly psychological symptoms through modulation of brain chemicals and gut-blood barrier disruption
Potential of Fasting as a Treatment for LCS Fasting shows promise as a treatment for LCS by modulating the same cellular systems affected by LCS A recent small study indicated that 92 of LCS patients experienced symptom improvement during long-term fasting with notable effects on circulating inflammatory molecules C-reactive protein levels and dyslipidemia Fasting can increase beneficial gut microbial genera and alter blood metabolites potentially disrupting dysfunctional circuits in LCS
Significance LCS affects over 150 million people worldwide with more than half experiencing significant work and lifestyle disruptions Effective low-cost and attainable therapeutic options are urgently needed Medically supervised fasting particularly intermittent fasting could be an accessible and safe intervention with minimal physician oversight and low malnutrition risk Fasting may also prevent other chronic illnesses associated with LCS such as type 2 diabetes mellitus
Hypothesis Our primary hypothesis is that ambulatory fasting intervention using the Buchinger-Wilhelmi method is a feasible treatment for LCS We propose that medically supervised long-term fasting will improve perceived health and quality of life in LCS patients by disrupting inflammatory immuno-metabolic feed-forward loops thus ameliorating immune and vascular pathologies
Methodology and Analysis Patient Eligibility
Inclusion Criteria
Age 18-64 Diagnosis of LCS post-acute COVID-19 symptoms persisting 12 weeks Normal BMI 185 to 25 kgm² Marginal iron status PF 25 ngml Ability to communicate in and comprehend English German or French Written and signed consent Willingness to consent to specimen collection and use
Exclusion Criteria
BMI 185 kgm² or significant recent weight loss History of eating disorders within the past five years Severe internal disease or chronic inflammatory illness other than LCS Participation in another intervention study Recent fasting or vegan diet Pregnancy or breastfeeding Existing MECFS or early autonomous dysfunction Chronic inflammatory bowel diseases celiac disease or colorectal cancer Use of anti-psychotic drugs or recent antibiotic use Contraindication for additional blood draws Start of novel drug therapy Intervention
The primary goal is to perform a single period of periodic fasting PF using the Buchinger procedure involving an initial bowel cleanse followed by a 7-day fasting period The fasting regimen includes
Preparation Phase Three days of relief with reduced food intake avoiding stimulants
Fasting Week A laxative fluid intake on the first day followed by 7 days of a dietary energy supply of a maximum of 350 kcal per day vegetable broths and juices and consumption of calorie-free water or tea
Support and Guidance Detailed instructions face-to-face consultations and digital application MyCap for adherence confirmation via urine ketone measurements
Sample and Data Collection Sample Size 20 patients for the pilot study to test feasibility
Study Outline
Inclusion visit for risk explanation medical history and physical examination
Daily follow-up via telephone and online appointments during the fasting phase Questionnaire-based assessment via MyCap Smartphone Application
Parameters to be Quantified
Blood samples for safety parameters metabolites immune activity indicators and additional analyses
Stool samples for microbiome composition and activity Urine samples for metabolomics Saliva samples for cortisol measurements Analysis and Results Interpretation Results will be analyzed descriptively with means standard deviations and graphs summarizing data Exploratory analysis will identify patterns trends or unexpected results Correlation with improvement in biomedical parameters will be assessed with a larger study needed for establishing causal links
Risks Blood Draw Discomfort bleeding swelling pain rare nerve damage or infection at the injection site and fainting risk
Periodic Fasting Protocol Reduction in blood pressure closely monitored with non-medical interventions if necessary
Data Collection and Storage Data is collected using REDCap a secure web-based software platform with pseudonymized data stored for at least 10 years post-study The Principal Investigator ensures compliance with national laws and GDPR
Regulatory and Ethical Considerations Informed Consent Participants receive an easily understood Participant Information Sheet and Informed Consent Form with contact information for study personnel
Confidentiality and Privacy Compliance with national laws and GDPR with pseudonymized data transfer to third parties only with participant consent
Financing and Insurance Supported by the Direction de la Santé CHNP and the University of Luxembourg
Conclusion This pilot study aims to test the feasibility of using the Buchinger-Wilhelmi fasting method for treating LCS If successful fasting could provide a low-cost accessible and effective therapeutic option for LCS sufferers worldwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None