Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2022-11-04
2024-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Arm AB (Diet then 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
Low sugar diet and 10-12 hour eating window
Low sugar diet and 10-12 hour eating window for four weeks
Low sugar diet, 8 hour eating window and fasting
Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.
Arm BA (Fasting then Diet)
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
Low sugar diet and 10-12 hour eating window
Low sugar diet and 10-12 hour eating window for four weeks
Low sugar diet, 8 hour eating window and fasting
Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.
Interventions
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Low sugar diet and 10-12 hour eating window
Low sugar diet and 10-12 hour eating window for four weeks
Low sugar diet, 8 hour eating window and fasting
Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.
Eligibility Criteria
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Inclusion Criteria
* Five or more common Long Covid symptoms
* Free from fever \> 100F and known bacterial and parasitic infections
* Must indicate willingness to limit certain supplements and report all medications.
* Must indicate willingness to make significant dietary changes - and limit daily eating to an 8 or 10 hour window.
* Must indicate willingness to attempt 36 hr or 60 hr water fasts each week for 4 weeks.
* Have a valid email address and phone number
* Reside in the United States
* Be able to read and to communicate in English
* Must indicate willingness to avoid "extra" supplements such as Fish Yes Oil, Cod liver Oil, Krill Oil, MCT oil, Coconut Oil, Tumeric/Curcumin, Berberine, Quercetin (\> 500 mg), Red Yeast Rice, French Marine Bark extract, Red Sage, Ginko biloba, Oregano Oil, Peppermint Oil, Black seed oil, Cinnamon bark extract, Elderberry, Stinging Nettle, Milk Thistle, Monolaurin, Vendicinals 9, Tollovid, QuadraMune and all Probiotics.
* Must indicate willingness to avoid certain nutraceuticals such as Zinc (more than 25 mg), Arginine, Glutamine, Palmitoylethanolamide (PEA), Alpha Lipoic Acid, L Carnitine and Taurine during the study period.
* Must indicate willingness to avoid longevity supplements such as NAD+, Niacin, NMN, Nicotinamide Riboside, Spermidine and Fisetin during the study period.
* Must indicate willingness to halt Olive oil consumption greater than 1 tsp daily during the study period.
Exclusion Criteria
* 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
19 Years
69 Years
ALL
No
Sponsors
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Pacific Northwest University of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Novack, PhD
Role: PRINCIPAL_INVESTIGATOR
Pacific Northwest University of Health Sciences
Locations
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Remote trial - anyone residing in the United States
Boulder, Colorado, United States
Pacific Northwest University
Yakima, Washington, United States
Countries
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References
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Stein SR, Ramelli SC, Grazioli A, Chung JY, Singh M, Yinda CK, Winkler CW, Sun J, Dickey JM, Ylaya K, Ko SH, Platt AP, Burbelo PD, Quezado M, Pittaluga S, Purcell M, Munster VJ, Belinky F, Ramos-Benitez MJ, Boritz EA, Lach IA, Herr DL, Rabin J, Saharia KK, Madathil RJ, Tabatabai A, Soherwardi S, McCurdy MT; NIH COVID-19 Autopsy Consortium; Peterson KE, Cohen JI, de Wit E, Vannella KM, Hewitt SM, Kleiner DE, Chertow DS. SARS-CoV-2 infection and persistence in the human body and brain at autopsy. Nature. 2022 Dec;612(7941):758-763. doi: 10.1038/s41586-022-05542-y. Epub 2022 Dec 14.
Cheung CCL, Goh D, Lim X, Tien TZ, Lim JCT, Lee JN, Tan B, Tay ZEA, Wan WY, Chen EX, Nerurkar SN, Loong S, Cheow PC, Chan CY, Koh YX, Tan TT, Kalimuddin S, Tai WMD, Ng JL, Low JG, Yeong J, Lim KH. Residual SARS-CoV-2 viral antigens detected in GI and hepatic tissues from five recovered patients with COVID-19. Gut. 2022 Jan;71(1):226-229. doi: 10.1136/gutjnl-2021-324280. Epub 2021 Jun 2. No abstract available.
Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
Diebold SS, Kaisho T, Hemmi H, Akira S, Reis e Sousa C. Innate antiviral responses by means of TLR7-mediated recognition of single-stranded RNA. Science. 2004 Mar 5;303(5663):1529-31. doi: 10.1126/science.1093616. Epub 2004 Feb 19.
Girdhar K, Powis A, Raisingani A, Chrudinova M, Huang R, Tran T, Sevgi K, Dogus Dogru Y, Altindis E. Viruses and Metabolism: The Effects of Viral Infections and Viral Insulins on Host Metabolism. Annu Rev Virol. 2021 Sep 29;8(1):373-391. doi: 10.1146/annurev-virology-091919-102416.
Gold JE, Okyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and Its Relationship to Epstein-Barr Virus Reactivation. Pathogens. 2021 Jun 17;10(6):763. doi: 10.3390/pathogens10060763.
Hannan MA, Rahman MA, Rahman MS, Sohag AAM, Dash R, Hossain KS, Farjana M, Uddin MJ. Intermittent fasting, a possible priming tool for host defense against SARS-CoV-2 infection: Crosstalk among calorie restriction, autophagy and immune response. Immunol Lett. 2020 Oct;226:38-45. doi: 10.1016/j.imlet.2020.07.001. Epub 2020 Jul 10.
Heil F, Hemmi H, Hochrein H, Ampenberger F, Kirschning C, Akira S, Lipford G, Wagner H, Bauer S. Species-specific recognition of single-stranded RNA via toll-like receptor 7 and 8. Science. 2004 Mar 5;303(5663):1526-9. doi: 10.1126/science.1093620. Epub 2004 Feb 19.
Kim H, Rebholz CM, Hegde S, LaFiura C, Raghavan M, Lloyd JF, Cheng S, Seidelmann SB. Plant-based diets, pescatarian diets and COVID-19 severity: a population-based case-control study in six countries. BMJ Nutr Prev Health. 2021 Jun 7;4(1):257-266. doi: 10.1136/bmjnph-2021-000272. eCollection 2021.
Koepke L, Hirschenberger M, Hayn M, Kirchhoff F, Sparrer KM. Manipulation of autophagy by SARS-CoV-2 proteins. Autophagy. 2021 Sep;17(9):2659-2661. doi: 10.1080/15548627.2021.1953847. Epub 2021 Jul 19.
Bunker T, Horne BD, Baldwin MD, Sorrells R, Turner S, Laube L, Solomon A, Horne LA, Novack J. Intermittent fasting and a no-sugar diet for Long COVID symptoms: a randomized crossover trial. Sci Rep. 2025 Jul 29;15(1):27563. doi: 10.1038/s41598-025-07461-0.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022-06-PNWU
Identifier Type: -
Identifier Source: org_study_id
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