Diet and Fasting for Long COVID

NCT06214455 | Completed

• 1 other identifier: 2022-06-PNWU
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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).

Conditions

Long Covid19; Long COVID

Keywords

COVID-19; fasting; diet

Outcome Measures

Primary Outcomes (2)

• Change in Long COVID Symptom Scores during Treatment A vs Treatment B

  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.

  4 weeks for each treatment

• Change in number of Long COVID symptoms during Treatment A vs Treatment B

  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.

  4 weeks for each treatment (delta from week 6 to week 2 or from week 10 to week 6)

Secondary Outcomes (3)

• Change in Long COVID Symptom Scores during the 10 week trial

  10 weeks (delta from week 10 to week 0)

• Change in number of Long COVID symptoms during the 10 week trial

  10 weeks (delta from week 10 to week 0)

• 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

Study Arms (2)

Arm AB (Diet then Fasting)

EXPERIMENTAL

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

Other: Low sugar diet and 10-12 hour eating window; Other: Low sugar diet, 8 hour eating window and fasting

Arm BA (Fasting then Diet)

EXPERIMENTAL

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

Other: Low sugar diet and 10-12 hour eating window; Other: Low sugar diet, 8 hour eating window and fasting

Interventions

Low sugar diet and 10-12 hour eating window OTHER

Low sugar diet and 10-12 hour eating window for four weeks

Arm AB (Diet then Fasting); Arm BA (Fasting then Diet)

Low sugar diet, 8 hour eating window and fasting OTHER

Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.

Arm AB (Diet then Fasting); Arm BA (Fasting then Diet)

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18-69 years old)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pacific Northwest University of Health Sciences: lead

Study Sites (2)

Remote trial - anyone residing in the United States

Boulder, Colorado, 80303, United States

Location

Pacific Northwest University

Yakima, Washington, 98901, United States

Location

Related Publications (11)

• 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.

  PMID: 36517603 BACKGROUND

• 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.

  PMID: 34083386 BACKGROUND

• 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.

  PMID: 34308300 BACKGROUND

• 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.

  PMID: 14976261 BACKGROUND

• 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.

  PMID: 34586876 BACKGROUND

• 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.

  PMID: 34204243 BACKGROUND

• 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.

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• 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.

  PMID: 14976262 BACKGROUND

• 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.

  PMID: 34308134 BACKGROUND

• 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.

  PMID: 34281462 BACKGROUND

• 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.

  PMID: 40730806 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Fasting

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeffrey Novack, PhD

  Pacific Northwest University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 19, 2024
• Study Start: November 4, 2022
• Primary Completion: July 1, 2024
• Study Completion: September 10, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)