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

NCT07745699 | Completed

• 1 other identifier: Keto-Life For Long COVID
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID Fatigue; Post COVID Dysautonomia

Keywords

Long COVID; Post COVID; post-viral dysautonomia; ketogenic metabolic therapy; infection-associated chronic illness; patient-perspectives; whole-person health design

Outcome Measures

Primary Outcomes (2)

• Acceptability

  Acceptability data were measured via participants' perception of treatment suitability using a 5-point Likert scale (e.g., 1 = Not at all helpful; 5 = Extremely helpful). Participants were asked to rate their level of satisfaction with the program, the perceived helpfulness and relevance of the program, and the likelihood of recommending the program to others. Assessment burden was measured using a 5-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). Participants were asked to rate the burden associated with sourcing food, cooking food, and completing assessment procedures. Further, acceptability was explored via questions pertaining to optimization of the study, including opinions on dosing and duration of the intervention.

  Acceptability data was collected at post-intervention (Week 13).

• Feasibility

  Feasibility of the research procedures and remote intervention was evaluated using metrics of enrollment (target sample size n = 10), attrition, population characteristics (e.g., percentage of participants identifying as non-white), completion of data-collection procedures within a 2-week window, amount of missing data, dietary adherence, and safety. The target sample size of 10 was selected to optimize group dynamics for the interactive, group-based components of the ketogenic metabolic therapy intervention, including weekly nutrition calls. Attendance at the weekly nutrition calls was recorded. We assessed adherence to dietary recommendations through participant self-report and objective metabolic data. Participants measured fasting capillary blood β-hydroxybutyrate (BHB) and fasting blood glucose using a commercially available, FDA-registered at-home device (Keto Mojo Meter, Keto Mojo, Inc.).

  Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).

Secondary Outcomes (6)

• PROMIS-29

  Baseline, Post-intervention (13 Week), and 3-month follow-up

• Duke Activity Status Index

  Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up

• Modified Medical Research Council Dyspnea Scale

  Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up

• Malmö POTS Symptom Score

  Baseline, Post-intervention (13 Weeks), and 3-month follow-up

• Good Day/Bad Day Questionnaire

  Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up

Study Arms (1)

ketogenic metabolic therapy with lifestyle strategies (KMT-LS)

EXPERIMENTAL

Other: Ketogenic Metabolic Therapy; Behavioral: Lifestyle Intervention

Interventions

Ketogenic Metabolic Therapy OTHER

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.

ketogenic metabolic therapy with lifestyle strategies (KMT-LS)

Lifestyle Intervention BEHAVIORAL

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.

ketogenic metabolic therapy with lifestyle strategies (KMT-LS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97229, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: A national, fully decentralized, single-arm, 12-week proof-of-concept study.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: December 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 4, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: De-identified individual participant data and supporting documents will be made available beginning 12 months after publication of the primary results and will remain available for 3 years. Requests received after this period will be considered on a case-by-case basis.
• Access Criteria: De-identified IPD that underlie the results reported in the published article will be shared with qualified researchers who submit a methodologically sound research proposal. Access requests should be directed to Dr. Dana Dharmakaya Colgan. Requestors must provide: (1) a brief research proposal describing the scientific question, analytic plan, and qualifications of the research team; (2) a signed data access and use agreement that includes provisions for data security, prohibition of re-identification, and restrictions on data sharing with third parties. Proposals will be reviewed by the study investigators. Approved requestors will receive access to de-identified data via a secure file-sharing platform. Data will not include any direct or indirect identifiers.

Locations

US (1)