Intermittent Fasting and a No-Sugar Diet for Long COVID Symptoms
The Effect of a No-added Sugar Diet, Time-restricted Eating and Periodic Water Fasting on Long COVID Symptoms
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jeffrey Novack, PhD
- Phone Number: 206-369-3967
- Email: jnovack@pnwu.edu
Study Contact Backup
- Name: Thomas W Bunker, PhD
- Phone Number: 720-470-1046
- Email: BunkColo@gmail.com
Study Locations
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Colorado
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Boulder, Colorado, United States, 80303
- Remote trial - anyone residing in the United States
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Washington
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Yakima, Washington, United States, 98901
- Pacific Northwest University
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: 10-12 hour daily Time-Restricted Eating (4 weeks)
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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Low sugar diet and 10-12 hour eating window for four weeks
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Experimental: 8-hour TRE, weekly 23 to 60 hour fast (4 weeks)
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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Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in LC-Score, Per Treatment
Time Frame: Before and after 4 weeks of Fasting treatment or TRE treatment
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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.
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Before and after 4 weeks of Fasting treatment or TRE treatment
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Change in Number of Long COVID Symptoms, Per Treatment
Time Frame: Before and after 4 weeks of Fasting treatment or TRE treatment
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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.
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Before and after 4 weeks of Fasting treatment or TRE treatment
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in LC-Score, Overall
Time Frame: From enrollment to the end of the final treatment (10 weeks)
|
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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From enrollment to the end of the final treatment (10 weeks)
|
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Change in Number of Long COVID Symptoms, Overall
Time Frame: From enrollment to the end of the final treatment (10 weeks)
|
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.
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From enrollment to the end of the final treatment (10 weeks)
|
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Serious Adverse Events
Time Frame: During 4 weeks of Fasting treatment or during 6 weeks of TRE
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Adverse events were medically reviewed and categorized as Serious if appropriate
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During 4 weeks of Fasting treatment or during 6 weeks of TRE
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jeffrey Novack, PhD, Pacific northwest university of health sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Behavior
- Feeding Behavior
- COVID-19
- Post-Acute COVID-19 Syndrome
- Fasting
Other Study ID Numbers
Other Study ID Numbers
- 2022-06-PNWU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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