- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418567
A Fasting Pilot Study for Long COVID
A Prospective Pilot Study to Evaluate the Feasibility of Prolonged Fasting for the Treatment of Long COVID Patients
Background Long COVID (LC) is a chronic multisystemic condition which substantially impact the quality of life. Despite the staggering burden of LC, there is still no effective treatment.
Because fasting promotes anti-inflammatory and antioxidant responses, which are involved in the pathophysiology of LC, we hypothesized that it might improve daily functioning and health-related quality of life in patients with LC.
The aim of this single center, one arm, prospective pilot clinical trial will be to assess the feasibility and acceptability of prolonged fasting for LC. The main questions aims to answers are;
- Does in-home prolonged fasting (7 days) is feasible and acceptable for patients with LC
- Is there a clinical benefit associated with fasting is LC patients
Participants (adults 18 year and older) will be asked to
- Fast for 7 days
- Have in-person visit at baseline (day 0) and at day 9 for checkups and tests
- Answer difference questionnnaires about their perceived health during and after fasting
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada
- Centre de recherche du CIUSSSE-CHUS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-64 years
- Diagnosis Long Covid based on WHO criteria (post-acute COVID-19 symptoms persisting ≥12 weeks) and validiated by an experienced cinician
- Normal body Mass Index (18.5 to 39 kg/m2)
- Able to communicate in and comprehend English and/or French language
- Present written / signed declaration of consent
- Ability to understand the patient information and willingness to sign the consent form
- Willing to limit physical activity during prolonged fasting
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.
- Current or history of eating disorder (e.g., anorexia, bulimia).
- Psychiatric condition that limits understanding of the examination protocol (unable to consent)
- Participation in another intervention study.
- Fasting during the last six months
- Pregnancy or breastfeeding status.
- Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the Canadian Society of Gastroenterology
- Use of anti-psychotic drugs
- Start of novel drug therapy for long COVID
- Contraindication for additional blood draws (e.g. hemoglobin <100)
- Taking opioid analgesics or undergoing treatment for opioid addiction
- Opioid dependence or withdrawal syndrome
- Type 1 or 2 Diabetes, or history of hypoglycemia
- Active cancer
- Baseline E+ (Na, K, Mg, phosphate) within normal range
- Baseline ALT < 60
- Baseline Hb > 100
- Baseline INR within normal range
- Baseline DFG < 50
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fasting arm
Participants will be allowed to continue their regular drug treatment
|
Participants will be fasting for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and Acceptability
Time Frame: From baseline (day 0) to end of follow up day 30
|
Retention rates will be used to measure feasibility and response to Likert-like questions for measuring acceptability
|
From baseline (day 0) to end of follow up day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean changes from baseline to one month post-fasting on the SF 36 physical component score questionnaire
Time Frame: From baseline (day 0) to the end of follow up at day 30
|
The SF 36 questionnaire is a validated scale for assessment and monitoring of patients with LC.
The 36-item scale includes 8 subscales : role functioning-physical, body pain, general health, vitality, social functioning, role functioning-emotional, and mental health.
|
From baseline (day 0) to the end of follow up at day 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue severity score (FSS)
Time Frame: From baseline (day 0) to end of follow up at day 30
|
The Fatigue severity scale (FSS) (0-7 score, 7 being worse) is one of the tool to assess the severity of fatigue.
It is validated for LC patients
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From baseline (day 0) to end of follow up at day 30
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Cognitive failure questinonaire
Time Frame: From baseline (day 0) to end of follow up (day 30)
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Assess cognitive impairment (25 questions, 0-100 score).Higher scores indicat increased propensity to cognitive impairment and it is validated for LC
|
From baseline (day 0) to end of follow up (day 30)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Behavior
- Feeding Behavior
- Post-Acute COVID-19 Syndrome
- Fasting
Other Study ID Numbers
- PF study
- Programme PAFI 2024-2025 (Other Identifier: Centre de recherche du CIUSSSE-CHUS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study Protocol
Information comments: christine.rioux-perreault.ciussse-chus@ssss.gouv.qc.ca
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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