RecruitingNot ApplicableNCT06522750

Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study

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


Sponsor

University of Luxembourg

Enrollment

20 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria8

  • 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

Exclusion Criteria13

  • 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
  • Participation in another intervention study.
  • Existing vegan diet or fasting during the last six months
  • Pregnancy or breastfeeding status.
  • Presence or suspicion of pre-existing ME/CFS or early autonomous dysfunction
  • Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the German Society of Gastroenterology
  • Use of anti-psychotic drugs
  • Antibiotic use during the previous 12 months
  • Start of novel drug therapy
  • Contraindication for additional blood draws (e.g. hemoglobin <10)

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Interventions

OTHER7-day ambulatory caloric restriction intervention using the Buchinger-Wilhelmi method

Buchinger-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.


Locations(1)

Rehaklinik CHNP

Ettelbruck, Luxembourg

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NCT06522750