Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study
NCT Number: NCT06522750
Acronym: FASTCOV-P
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long Covid|Chronic Inflammation
Interventions: OTHER: 7-day ambulatory caloric restriction intervention using the Buchinger-Wilhelmi method
Sponsor: University of Luxembourg
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-15
Completion Date: 2024-12-30

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 patients\&#39; 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.

Primary Outcome Measures: Nutritional protocol, Patient's level of health and wellbeing from a nutritional point of view, 4 weeks|Fatigue assessment Scale (FAS), Level of fatigue through three factors (General Fatigue, Physical Fatigue and Concentration/Motivation)., 4 weeks|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., 4 weeks|Functionality (WHODAS 2.0), Impact of Long Covid in terms of functioning., 4 weeks|Anxiety (GAD-7), Generalized anxiety disorder in the last 2 weeks, 4 weeks|Depression (PHQ-9), Presence and severity of depressive symptoms, 4 weeks|Mood States, Transient fluctuating moods or affective states, 4 weeks|Blood preasure, Force or pressure of blood on the arteries when the heart is pumping, 4 weeks
Secondary Outcome Measures: Urine Metabolomics, Metabolites in urine, 4 weeks|Gut Microbiome, Microbiota in stool, 4 weeks|Stool Metabolomics, Metabolites in stool, 4 weeks|Blood cytokines, Cytokines using Quanterix technology, 4 weeks|Blood Mitochondrial dysfunction, Mitochondrial cell-free DNA, 4 weeks|Blood Epigenetics, Methylation profiling microarray, 4 weeks|Blood test, Metabolites in blood, 4 weeks