NCT06522750 Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study
| NCT ID | NCT06522750 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Luxembourg |
| Condition | Long Covid |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-19 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-19 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Raquel Gomez Bravo, PhD
PRINCIPAL INVESTIGATOR
Rehaklinik du Centre Hospitalier Neuro-Psychiatrique (CHNP), UL
Frequently Asked Questions
Who can join the NCT06522750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Long Covid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06522750 currently recruiting?
Yes, NCT06522750 is actively recruiting participants. Contact the research team at marta.sanchez@uni.lu for enrollment information.
Where is the NCT06522750 trial being conducted?
This trial is being conducted at Ettelbruck, Luxembourg.
Who is sponsoring the NCT06522750 clinical trial?
NCT06522750 is sponsored by University of Luxembourg. The principal investigator is Raquel Gomez Bravo, PhD at Rehaklinik du Centre Hospitalier Neuro-Psychiatrique (CHNP), UL. The trial plans to enroll 20 participants.
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