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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low sugar diet and 10-12 hour eating window | Other | Low sugar diet and 10-12 hour eating window for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LC-Score, Overall | This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) at baseline from the LC-Score after the final 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. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Novack, PhD | Pacific Northwest University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote trial - anyone residing in the United States | Boulder | Colorado | 80303 | United States | ||
| Pacific Northwest University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40730806 | Result | 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. |
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No current plan to share data with other researchers.
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Participants were randomly assigned to do treatment A then Treatment B ( Group AB) or to do Treatment B then Treatment A (Group BA). All participants first did a two-week baseline of 10-12 hr TRE before beginning the two four week treatment periods.
Between November 2022 and April 2024, a total of 424 individuals were prescreened via pragmatic electronic means. Of these, 105 proceeded to screening and enrollment via video interview and consenting. A total of 77 participants enrolled and began a treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRE Then Fasting | Group AB did treatment A for 4 weeks followed by treatment B for 4 weeks. Treatment A (hereafter called TRE) was a no-sugar diet with a 10-12 hour daily TRE eating window. Treatment B (hereafter called Fasting) was the same no-sugar diet with a more restrictive 8-hour daily TRE eating window (and 16 consecutive hours of not eating), along with a once weekly 23-60 h water-only fast. |
| FG001 | Fasting Then TRE | Group BA did treatment B for 4 weeks followed by treatment A for 4 weeks. Treatment B (hereafter called Fasting) was the same no-sugar diet with a more restrictive 8-hour daily TRE eating window (and 16 consecutive hours of not eating), along with a once weekly 23-60 h water-only fast. Treatment A (hereafter called TRE) was a no-sugar diet with a 10-12 hour daily TRE eating window. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (2 weeks) |
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| First Intervention (4 weeks) |
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| 2nd Intervention (4 weeks) |
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Only those participants that successfully completed the full trial and followed the protocol as designed are included.
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| ID | Title | Description |
|---|---|---|
| BG000 | TRE Then Fasting | Group AB did A for 4 weeks followed by treatment B for 4 weeks. Treatment A (hereafter called TRE) was a no-sugar diet with a 10-12 hour daily TRE eating window. Treatment B (hereafter called Fasting) was the same no-sugar diet with a more restrictive 8-hour daily TRE eating window (and 16 consecutive hours of not eating), along with a once weekly 23-60 h water-only fast. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants aged 18 to 69 were eligible for the trial |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Because this is a crossover trial, all participants did both treatments, one group did TRE then Fasting, the other group did Fasting then TRE. Only those participants that successfully completed the full trial and followed the protocol as designed are included. | Posted | Mean | Standard Deviation | Scores on a Scale | Before and after 4 weeks of Fasting treatment or TRE treatment |
|
From initial baseline symptom survey until completion of both treatments 10-weeks later.
Adverse events were captured via participant weekly symptom surveys. They were reviewed by the study doctor and classified as Serious or Other. Because many of the common symptoms of Long COVID are incapacitating, especially during flare-ups, serious adverse events were limited to those that required hospitalization or those that were considered medically serious upon review by the study doctor. Any unusual or concerning health event was tracked as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Week Baseline | All 77 participants that began the trial. Participants followed a no-sugar diet and 10-12 hour time-restricted eating for the baseline 2-week period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute appendicitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Long COVID flare-up symptoms | General disorders | Non-systematic Assessment | Typically increased brain fog, headache, fatigue, irritability and nerve/muscle soreness |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery Novack | Pacific Northwest University of Health Sciences | 2063693967 | jnovack@pnu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2023 | Jul 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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2-week baseline period with adoption of no-sugar diet followed by treatment AB or treatment BA in a randomized crossover design.
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| 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. |
|
| From enrollment to the end of the final treatment (10 weeks) |
| Change in Number of Long COVID Symptoms, Overall | This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) at baseline from the numLCsym after the final 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. | From enrollment to the end of the final treatment (10 weeks) |
| Serious Adverse Events | Adverse events were medically reviewed and categorized as Serious if appropriate | During 4 weeks of Fasting treatment or during 6 weeks of TRE |
| Yakima |
| Washington |
| 98901 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Fasting Then TRE | Group BA did treatment B for 4 weeks followed by treatment A for 4 weeks. Treatment B (hereafter called Fasting) was the same no-sugar diet with a more restrictive 8-hour daily TRE eating window (and 16 consecutive hours of not eating), along with a once weekly 23-60 h water-only fast. Treatment A (hereafter called TRE) was a no-sugar diet with a 10-12 hour daily TRE eating window. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Long COVID Score (LC-Score) | The sum of severity scores (0-4) for 28 common symptoms plus the count of 32 additional symptoms present. Higher scores indicate worse Long COVID and a score of zero indicates no Long COVID symptoms. The maximum possible LC-Score is (28x4)+32 = 144. | Mean | Standard Deviation | Scores on a Scale |
|
| Number of Long COVID symptoms (numLCsym) | The number of patient-reported Long COVID symptoms from a list of 60 symptoms. The maximum value is 60. | Mean | Standard Deviation | Number of Symptoms |
|
| Duration of Long COVID symptoms | Duration of Long COVID symptoms in months since inital onset of symptoms | Mean | Standard Deviation | Months |
|
4 weeks of eating in an 8 hour window per day, with a no added sugar diet and a night-day-night water fast once per week.
Because this is a crossover trial, the change in the Fasting treatment 4 weeks compared to the change in the TRE treatment 4 weeks was compared for all members of the analytic group.
| OG001 | TRE 4 Weeks | Time-Restricted Eating for 10 -12 hours per day with a no added sugar diet. |
|
|
| Primary | 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. | Because this is a crossover trial, all participants did both treatments, one group did TRE then Fasting, the other group did Fasting then TRE. Only those participants that successfully completed the full trial and followed the protocol as designed are included. | Posted | Mean | Standard Deviation | Number of Symptoms | Before and after 4 weeks of Fasting treatment or TRE treatment |
|
|
|
| Secondary | Change in LC-Score, Overall | This Outcome Measure is calculated by subtracting the Long COVID symptom severity score (LC-Score) at baseline from the LC-Score after the final 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. | Posted | Mean | Standard Deviation | Scores on a Scale | From enrollment to the end of the final treatment (10 weeks) |
|
|
|
| Secondary | Change in Number of Long COVID Symptoms, Overall | This Outcome Measure is calculated by subtracting the Number of Long COVID symptoms (numLCsym) at baseline from the numLCsym after the final 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. | Posted | Mean | Standard Deviation | Number of Symptoms | From enrollment to the end of the final treatment (10 weeks) |
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| Secondary | Serious Adverse Events | Adverse events were medically reviewed and categorized as Serious if appropriate | Adverse events were tracked for all trial participants, not just the final analytic group of 58 | Posted | Number | Number of Serious Adverse Events | During 4 weeks of Fasting treatment or during 6 weeks of TRE |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 11 |
| 77 |
| EG001 | TRE Treatment | All participants that began their 4-week TRE treatment period. Time-Restricted Eating for 10 -12 hours per day with a no added sugar diet. | 0 | 70 | 1 | 70 | 19 | 70 |
| EG002 | Fasting Treatment | All participants that began their 4-week Fasting treatment period. 4 weeks of eating in an 8 hour window per day, with a no added sugar diet and a night-day-night water fast once per week. | 0 | 66 | 1 | 66 | 17 | 66 |
| pleurisy, tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Overnight hospitalization for left-side pleurisy, inflammation, and bicep tendonitis after 38-h of fasting |
|
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| Viral infection (Flu or COVID-19) | General disorders | Non-systematic Assessment | Typical infection symptoms as from a Flu or COVID-19 infection |
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| Vaccination reaction | General disorders | Non-systematic Assessment |
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| Tachycardia or Chest pains | Cardiac disorders | Non-systematic Assessment | Patient-reported chest pain or racing heart |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | patient reported |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |