Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID (NCT07745699) | Clinical Trial Compass
CompletedNot Applicable
Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID
United States11 participantsStarted 2024-12-10
Plain-language summary
The goal of this clinical trial is to learn if a 12-week ketogenic diet program combined with lifestyle strategies (called KMT-LS) is practical and acceptable as a fully remote intervention for adults with Long COVID who also have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. (ME/CFS) and dysautonomia (problems with heart rate, blood pressure, or other automatic body functions).
The main questions it aims to answer are:
Can a ketogenic diet program be successfully delivered entirely from home using online tools and virtual support?
Do participants stay in the study, follow the diet, and find the program safe and satisfactory?
Do participants experience improvements in fatigue, sleep, mood, daily functioning, and symptom flare-ups after exertion?
Participants will:
Follow a ketogenic diet for 12 weeks with weekly virtual nutrition support sessions
Use at-home tools to track their ketone levels and confirm they are following the diet
Complete online questionnaires about their symptoms, energy, sleep, mood, and daily functioning at the start of the study, after 12 weeks, and again 3 months later.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age 18 years or older
English-speaking
Suspected, probable, or confirmed SARS-CoV-2 infection as defined by the Pan American Health Organization
Long COVID diagnosed via structured clinical interview, consistent with the World Health Organization clinical case definition and the National Academies of Sciences, Engineering, and Medicine (2024) definition
Physician-confirmed diagnosis of post-infectious dysautonomia and ME/CFS; OR self-reported dysautonomia symptoms with a Malmö POTS Score Assessment (MAPS) score greater than 40
Met the National Academy of Medicine diagnostic criteria for ME/CFS
Exclusion Criteria:
* Known pregnancy or planning pregnancy during the study period
Active cancer diagnosis
Renal or liver failure
Pancreatitis
Atrial fibrillation or significant cardiac arrhythmia
Significant atherosclerotic disease
Uncontrolled hypertension or hypertriglyceridemia
Active or recent thrombosis
Use of antiepileptic medications
Use of SGLT-2 inhibitors
Substance use disorder
Type I diabetes
History of inborn errors of metabolism
Previous completion of a nutritional and lifestyle program for this condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability
Timeframe: Acceptability data was collected at post-intervention (Week 13).
2
Feasibility
Timeframe: Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).