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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
77
Low sugar diet and 10-12 hour eating window for four weeks
Low sugar diet, 8 hour eating window and a 36-60 hour fast once per week for four weeks.
Remote trial - anyone residing in the United States
Boulder, Colorado, United States
Pacific Northwest University
Yakima, Washington, United States
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.
Time frame: 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.
Time frame: Before and after 4 weeks of Fasting treatment or TRE treatment
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.
Time frame: 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.
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Time frame: 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
Time frame: During 4 weeks of Fasting treatment or during 6 weeks of TRE