Diet and Fasting for Long COVID

NCT ID: NCT06214455

Last Updated: 2025-07-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-04

Study Completion Date

2024-09-10

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Long Covid19 Long COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type EXPERIMENTAL

Low sugar diet and 10-12 hour eating window

Intervention Type OTHER

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

Low sugar diet, 8 hour eating window and fasting

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Low sugar diet and 10-12 hour eating window

Intervention Type OTHER

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

Low sugar diet, 8 hour eating window and fasting

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacific Northwest University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Pacific Northwest University

Yakima, Washington, United States

Site Status

Countries

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United States

References

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Reference Type DERIVED
PMID: 40730806 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2022-06-PNWU

Identifier Type: -

Identifier Source: org_study_id

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