Pilot Study on the Feasibility of an RCT: Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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\' 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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)

• Able to communicate in and comprehend English and/or German and/or French language

• Present written / signed declaration of consent

• Ability to understand the patient information and willingness to sign the consent form

• Consent to specimen collection and specimen use

Locations
Other Locations
Luxembourg
Rehaklinik CHNP
RECRUITING
Ettelbruck
Contact Information
Primary
Marta Sanchez, PhD
marta.sanchez@uni.lu
+3524666446555
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 20
Treatments
Experimental: 20 participants. Long covid patients.
All patients will undergo a caloric restriction diet for a week.This begins with the intake of a laxative fluid on the first fasting day. This fluid aids in bowel emptying, akin to preparations for a colonoscopy. Detailed instructions on how to use it will be provided along with the laxative, and the study physician or dietary team will discuss dosage and intake with you. The caloric restriction period will last for 7 days and then be broken with the consumption of an apple. Following the breaking of the fast, three build-up days will follow to gradually increase food intake.
Related Therapeutic Areas
Sponsors
Leads: University of Luxembourg

This content was sourced from clinicaltrials.gov