NCT06214455

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
1 year until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

January 3, 2023

Results QC Date

January 12, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

COVID-19; fastingdiet

Outcome Measures

Primary Outcomes (2)

  • Change in LC-Score, Per Treatment

    This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) before a treatment from the LC-Score after the treatment (i.e., score-after minus score-before). Negative values represent a reduction in number and severity of symptoms following treatment. LC-Scores are the sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. The maximum possible LC-Score is (28x4)+32 = 144.

    Before and after 4 weeks of Fasting treatment or TRE treatment

  • Change in Number of Long COVID Symptoms, Per Treatment

    This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) before a treatment from the numLCsym after the treatment (i.e., number-after minus number-before). Negative values represent a reduction in number of symptoms following treatment. The numLCsym is the count of 60 common symptoms.

    Before and after 4 weeks of Fasting treatment or TRE treatment

Secondary Outcomes (3)

  • Change in LC-Score, Overall

    From enrollment to the end of the final treatment (10 weeks)

  • Change in Number of Long COVID Symptoms, Overall

    From enrollment to the end of the final treatment (10 weeks)

  • Serious Adverse Events

    During 4 weeks of Fasting treatment or during 6 weeks of TRE

Study Arms (2)

10-12 hour daily Time-Restricted Eating (4 weeks)

ACTIVE COMPARATOR

In this crossover trial, half the participants did the 10-hour TRE first (treatment A), half did it last. A no added sugar diet was suggested for the entire study.

Other: Low sugar diet and 10-12 hour eating window

8-hour TRE, weekly 23 to 60 hour fast (4 weeks)

EXPERIMENTAL

Eating in an 8-hour window daily, with one 23-60 hour fast per week. A no-added sugar diet was suggested.

Other: Low sugar diet, 8 hour eating window and fasting

Interventions

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

10-12 hour daily Time-Restricted Eating (4 weeks)

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

8-hour TRE, weekly 23 to 60 hour fast (4 weeks)

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 (1)

  • 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.

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCOVID-19Fasting

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Limitations and Caveats

Limitations include no follow-up symptom surveys after the intervention period to assess the durability of patient gains. This trial relied on patient-reported symptoms and severity assessment since there are no available biomarkers for Long COVID. Finally, although subjects were excluded if they had a prior chronic health condition, changes in other factors not related to the fasting interventions may have impacted participant symptoms, which could bias outcomes.

Results Point of Contact

Title
Jeffery Novack
Organization
Pacific Northwest University of Health Sciences

Study Officials

  • Jeffrey Novack, PhD

    Pacific Northwest University of Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 2-week baseline period with adoption of no-sugar diet followed by treatment AB or treatment BA in a randomized crossover design.
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

May 14, 2026

Results First Posted

May 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No current plan to share data with other researchers.

Locations