About this trial
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 patients\' 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-64
Diagnosis Long Covid Syndrome (post-acute COVID-19 symptoms persisting ≥12 weeks)
Normal body Mass Index (18.5 to 25 kg/m2)
Marginal Iron status ( PF< 25 ng/ml)
Disqualifiers
Current underweight condition (body mass index less than 18.5 kg/m2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.
Existing / current eating disorder within the past five years (e.g., anorexia, bulimia).
Psychiatric condition that limits understanding of the examination protocol (unable to consent)
Severe internal disease (e.g. kidney deficiency with creatinine > 2mg/dl), chronic inflammatory illness other than LCS
Trial design
Single group
Treatments tested in this trial
7-day ambulatory caloric restriction intervention using the Buchinger-Wilhelmi method
Other interventionBuchinger-Wilhelmi method, will be administered in an ambulatory setting under physician guidance. It involves an initial bowel cleanse followed by 7-day fasting period. The initial bowel cleanse will be performed according to the standard procedure commonly used for colonoscopy preparation. During the fasting period, subjects will be provided with a dietary energy supply of a maximum of 350 kcal per day, primarily consisting of vegetable broths as well as fresh vegetable juices. Patients will only be allowed to consume calorie-free and unsweetened water or tea in addition to the prescribed diet.
Treatment groups
Trial outcomes
Primary outcomes
Nutritional protocol
Patient's level of health and wellbeing from a nutritional point of view
Fatigue assessment Scale (FAS)
Level of fatigue through three factors (General Fatigue, Physical Fatigue and Concentration/Motivation).
Quality of Life (WHOQOL)
Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
Functionality (WHODAS 2.0)
Impact of Long Covid in terms of functioning.
Secondary outcomes
Urine Metabolomics
Metabolites in urine
Gut Microbiome
Microbiota in stool
Stool Metabolomics
Metabolites in stool
Blood cytokines
Cytokines using Quanterix technology
Sponsors and contacts
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