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

3 août 2026 mis à jour par: Dharma Colgan, National University of Natural Medicine

A National, Fully Decentralized, Telehealth-Based Ketogenic Metabolic Therapy Intervention for Individuals With Long COVID: A 12-Week, Single-Arm Feasibility and Acceptability Trial Targeting ME/CFS and POTS Phenotypes

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

11

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Oregon
      • Portland, Oregon, États-Unis, 97229
        • National University of Natural Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
Autre: 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.

Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Acceptability
Délai: Acceptability data was collected at post-intervention (Week 13).
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
Délai: Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).
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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PROMIS-29
Délai: Baseline, Post-intervention (13 Week), and 3-month follow-up
PROMIS-29 to assess self-reported levels of physical, social, and cognitive functioning, anxiety, depression, pain interference, and sleep disturbance. Each subscale is standardized to a T-score (Mean = 50, SD = 10), where higher scores represent more of the concept being measured (e.g., more anxiety or better physical function). A threshold of 3 T-score points is considered a minimal clinically important difference (MCID) for each subscale
Baseline, Post-intervention (13 Week), and 3-month follow-up
Duke Activity Status Index
Délai: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Measured functional capacity using a 12-item self-report questionnaire that assesses the ability to perform specific activities of daily living. Each item is weighted by its metabolic equivalent value, with total scores ranging from 0 to 58.2. Higher scores indicate greater functional capacity and serve as a validated surrogate marker for peak oxygen uptake .
Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Modified Medical Research Council Dyspnea Scale
Délai: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Measures respiratory limitation, which categorizes breathlessness on a 5-point scale (Grade 0-4) based on the level of physical exertion required to elicit shortness of breath. A 1-point increase represents a significant decline in function and is recognized as the MCID.
Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Malmö POTS Symptom Score
Délai: Baseline, Post-intervention (13 Weeks), and 3-month follow-up
MAPS is a self-rated, 12-item visual analogue instrument (0-10 per symptom, total 0-120) that measures orthostatic and autonomic burden. Each item scores current symptom burden; higher totals indicate greater symptom severity.
Baseline, Post-intervention (13 Weeks), and 3-month follow-up
Good Day/Bad Day Questionnaire
Délai: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
The Bateman Horne Center Good Day/Bad Day Questionnaire is not scored as a symptom-severity index; its two anchors are Hours of Upright Activity (HUA) and the number/proportion of good days, both of which are functional-capacity metrics. More upright hours and a higher good:bad day ratio indicate greater functional capacity and less PEM burden; lower values indicate more severe illness.
Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
Satisfaction with Life Scale
Délai: Baseline, Post-intervention (13-Weeks), and 3-month follow-up
Evaluates global life satisfaction using a 5-item instrument that uses a 7-point Likert scale to assess an individual's conscious evaluative judgment of their life. Scores range from 5 (Extremely dissatisfied) to 35 (Extremely satisfied).
Baseline, Post-intervention (13-Weeks), and 3-month follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National University of Natural Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 décembre 2024

Achèvement primaire (Réel)

1 juin 2025

Achèvement de l'étude (Réel)

1 juin 2025

Dates d'inscription aux études

Première soumission

29 juillet 2026

Première soumission répondant aux critères de contrôle qualité

2 août 2026

Première publication (Réel)

4 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2026

Dernière vérification

1 novembre 2024

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Keto-Life For Long COVID

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Deidentified clinical data

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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