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

3. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

11

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97229
        • National University of Natural Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
Sonstiges: 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.

Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability
Zeitfenster: 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
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS-29
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National University of Natural Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Dezember 2024

Primärer Abschluss (Tatsächlich)

1. Juni 2025

Studienabschluss (Tatsächlich)

1. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. August 2026

Zuerst gepostet (Tatsächlich)

4. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. August 2026

Zuletzt verifiziert

1. November 2024

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Keto-Life For Long COVID

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Deidentified clinical data

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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