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

NCT06522750 | Recruiting

• 1 other identifier: 202401/03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Long Covid; Chronic Inflammation

Keywords

long covid; fasting; caloric restriction; chronic inflammation; dysbiosis; mitochondrial dysfunction; thrombosis

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• Urine Metabolomics

  4 weeks

• Gut Microbiome

  4 weeks

• Stool Metabolomics

  4 weeks

• Blood cytokines

  4 weeks

• Blood Mitochondrial dysfunction

  4 weeks

Study Arms (1)

20 participants. Long covid patients.

EXPERIMENTAL

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.

Other: 7-day ambulatory caloric restriction intervention using the Buchinger-Wilhelmi method

Interventions

7-day ambulatory caloric restriction intervention using the Buchinger-Wilhelmi method OTHER

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.

20 participants. Long covid patients.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Luxembourg: lead

Study Sites (1)

Rehaklinik CHNP

Ettelbruck, L-9012, Luxembourg

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fasting; Dysbiosis; Mitochondrial Diseases; Thrombosis

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Metabolic Diseases; Nutritional and Metabolic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raquel Gomez Bravo, PhD

  Rehaklinik du Centre Hospitalier Neuro-Psychiatrique (CHNP), UL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Sanchez, PhD

CONTACT

+3524666446555; marta.sanchez@uni.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: July 26, 2024
• Study Start: February 19, 2025
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

LU (1)