Pilot Study on the Feasibility of an RCT: Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fatigue assessment Scale (FAS)
研究概览
简要总结
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.
详细描述
Background Long COVID syndrome (LCS) is a heterogeneous clinical condition that develops after acute SARS-CoV-2 infection, affecting at least 10% of patients. LCS is characterized by persistent symptoms lasting longer than 2-3 months following a confirmed SARS-CoV-2 infection. The most disruptive symptoms include fatigue, shortness of breath, pain, depression/anxiety, and cognitive impairment, significantly impacting daily activities, income, and quality of life.
Pathophysiology of LCS
Immunological Dysregulation:
Persistent activation of monocyte populations, including resident and infiltrating macrophages, dendritic cells, and neutrophils, potentially causing tissue damage.
Reservoirs of SARS-CoV-2 may persist, particularly in respiratory and gastrointestinal tracts, contributing to ongoing lymphocyte activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Fatigue assessment Scale (FAS)
时间窗: 4 weeks
Level of fatigue through three factors (General Fatigue, Physical Fatigue and Concentration/Motivation).
Quality of Life (WHOQOL)
时间窗: 4 weeks
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.
Functionality (WHODAS 2.0)
时间窗: 4 weeks
Impact of Long Covid in terms of functioning.
Mood States
时间窗: 4 weeks
Transient fluctuating moods or affective states
Depression (PHQ-9)
时间窗: 4 weeks
Presence and severity of depressive symptoms
Nutritional protocol
时间窗: 4 weeks
Patient's level of health and wellbeing from a nutritional point of view
Anxiety (GAD-7)
时间窗: 4 weeks
Generalized anxiety disorder in the last 2 weeks
Blood preasure
时间窗: 4 weeks
Force or pressure of blood on the arteries when the heart is pumping
次要结局
- Blood cytokines(4 weeks)
- Stool Metabolomics(4 weeks)
- Blood test(4 weeks)
- Gut Microbiome(4 weeks)
- Blood Mitochondrial dysfunction(4 weeks)
- Urine Metabolomics(4 weeks)
- Blood Epigenetics(4 weeks)