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Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID
Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID

NCT07745699

CompletedNA

Sponsor: National University of Natural Medicine

Conditions: Long COVID Fatigue

Interventions: Ketogenic Metabolic Therapy, Lifestyle Intervention

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Portland, Oregon, United States