Diet and Fasting for Long COVID
- Conditions
- Long COVIDLong Covid19
- Interventions
- Other: Low sugar diet and 10-12 hour eating windowOther: Low sugar diet, 8 hour eating window and fasting
- Registration Number
- NCT06214455
- Lead Sponsor
- Pacific Northwest University of Health Sciences
- Brief Summary
This cross-over study will assess a no added sugar diet, a restricted daily eating window, and one or two full day water fasts to determine if there is an effect on self-reported symptoms of Long Covid (PASC).
- Detailed Description
This remote study will use a cross-over design to test a diet change plus a 10-12 hour eating window (Treatment A) compared to a diet change, an 8-hour eating window, and one 36 or 60 hour fast per week (Treatment B). Both potential Treatment A and potential Treatment B are 4 weeks in duration. To be eligible, subjects must have a minimum of five common long COVID-19 symptoms. The fasting will limit food intake but not water intake. There will be a two-week run-in with weekly surveys of patient-reported symptoms and severity. The subjects will be randomly assigned to Group AB or to Group BA. Since the water fasts are at the beginning of the week (with symptoms surveyed at the end of the week) there is a 5-6 day washout and then a cross-over to the other treatment for Group BA. A Likert 0-4 scale is used to track the severity of 28 of the most common patient-reported symptoms each week. An additional 30 symptoms are also tracked. Subjects are asked to follow a no-added sugar diet for the entire 10 weeks of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
- Likely COVID-19 or SARS-CoV-2 infection < 45 days before enrollment
- Body Mass Index (BMI) must be 20 or greater
- Past history of an eating disorder.
- Previously fasted more than 18 hours with Long COVID
- Currently doing intermittent fasting
- Pregnant or breast-feeding
- Severe pulmonary disease requiring supplemental oxygen
- Partial loss of vision due to macular degeneration
- Any recent (90 days) history of malignancies, fractures, surgery, radiation, chemo, anesthesia, or traumas
- Diagnosed with Type I or Type II Diabetes
- Previous Autoimmune condition
- Heart condition (Coronary artery disease, Heart valve disease, Heart No failure, Stroke)
- Pre-pandemic Arrythmia
- Liver disease
- Previous Chronic Health Conditions that did not fully resolve (Includes ME/CFS, Lyme Disease, and Fibromyalgia)
- Prescription anticoagulation medication that cannot be halted during the study period. Brilinta (ticagrelor), Plavix (clopidogrel), Coumadin, Warfarin etc.
- High Cholesterol medications that cannot be halted or reduced during the study period (Fenofibrate, Statins > 10 mg)
- Anti-inflammatories or immunosuppressants such as Steroids, Low dose Naltrexone (LDN), Maraviroc, Remicade/Infliximab or Colchicine that cannot be halted during the study period
- Metformin, Ivermectin, or peptides such as BCP-157 that cannot be halted during the study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm AB (Diet then Fasting) Low sugar diet and 10-12 hour eating window 2 week baseline with a low sugar diet and 10-12 eating window Treatment A: Eat a low sugar diet, 10-12 hour eating window for four weeks Treatment B: Eat a low sugar diet, 8 hour eating window, 23 to 60 hour fast once a week for four weeks Arm BA (Fasting then Diet) Low sugar diet, 8 hour eating window and fasting 2 week baseline with a low sugar diet and 10-12 eating window Treatment B: Eat a low sugar diet, 8 hour eating window, 23 to 60 hour fast once a week for four weeks Treatment A: Eat a low sugar diet, 10-12 hour eating window for four weeks Arm AB (Diet then Fasting) Low sugar diet, 8 hour eating window and fasting 2 week baseline with a low sugar diet and 10-12 eating window Treatment A: Eat a low sugar diet, 10-12 hour eating window for four weeks Treatment B: Eat a low sugar diet, 8 hour eating window, 23 to 60 hour fast once a week for four weeks Arm BA (Fasting then Diet) Low sugar diet and 10-12 hour eating window 2 week baseline with a low sugar diet and 10-12 eating window Treatment B: Eat a low sugar diet, 8 hour eating window, 23 to 60 hour fast once a week for four weeks Treatment A: Eat a low sugar diet, 10-12 hour eating window for four weeks
- Primary Outcome Measures
Name Time Method Change in Long COVID Symptom Scores during Treatment A vs Treatment B 4 weeks for each treatment Long COVID Symptom Severity Scores are calculated from weekly surveys using a (0-4) severity scale for each of 28 patient-reported symptoms commonly found in Long COVID. The symptom severity values are summed for each participant. That severity subtotal is then added to the number of 30 additional symptoms that were reported.
Change in number of Long COVID symptoms during Treatment A vs Treatment B 4 weeks for each treatment (delta from week 6 to week 2 or from week 10 to week 6) The total number of patient-reported symptoms is calculated from the weekly symptom surveys. The value at the end of the 4 week treatment period is subtracted from the value at the beginning of the 4 week treatment period.
- Secondary Outcome Measures
Name Time Method Change in Long COVID Symptom Scores during the 10 week trial 10 weeks (delta from week 10 to week 0) Long COVID Symptom Severity Scores are calculated from weekly surveys using a (0-4) severity scale for each of 28 patient-reported symptoms commonly found in Long COVID. The symptom severity values are summed for each participant. That severity subtotal is then added to the number of 30 additional symptoms that were reported.
Change in number of Long COVID symptoms during the 10 week trial 10 weeks (delta from week 10 to week 0) The total number of patient-reported symptoms is calculated from the weekly symptom surveys. The value at the end of the 4 week treatment period is subtracted from the value at the beginning of the 4 week treatment period.
Number of participants With Serious and Concerning Adverse Events 2 week baseline, 4 weeks for Treatment A, 4 weeks for Treatment B, 10 weeks of the study All adverse events will be medically reviewed and judged to be; not related, possibly related, or definitely related to the treatment intervention.
Trial Locations
- Locations (2)
Remote trial - anyone residing in the United States
🇺🇸Boulder, Colorado, United States
Pacific Northwest University
🇺🇸Yakima, Washington, United States