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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
A national, fully decentralized, single-arm, 12-week proof-of-concept study.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
  • Other: Ketogenic Metabolic Therapy
    Keto-Life is a fully remote, community-based program for individuals with Long COVID, dysautonomia, and ME/CFS that combines a ketogenic diet with lifestyle strategies. Participants followed a ketogenic diet (low-carbohydrate, moderate-protein, high-fat) with a personalized intermittent eating schedule, no added sugar, and daily benfotiamine (vitamin B1) supplementation. Electrolyte support included magnesium, potassium, sodium bicarbonate, and sodium chloride. Nutrition calls were once a week via Telehealth platform, delivered by a medical nutritionist.
  • Behavioral: Lifestyle Intervention
    Lifestyle strategies included circadian entrainment, mindfulness practices, and, when appropriate, gentle exercise and hormetic therapies such as cold or heat exposure. The Lifestyle Intervention was delivered via two 60-minute virtual group sessions, delivered by health coaches.

Recruiting Locations

More Details

NCT ID
NCT07745699
Status
Completed
Sponsor
National University of Natural Medicine

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.