Fully Remote, Telehealth-based Ketogenic Metabolic Therapy for Long COVID
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Oregon
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Portland, Oregon, Förenta staterna, 97229
- National University of Natural Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
|
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. 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptability
Tidsram: 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
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PROMIS-29
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Post-infektionssjukdomar
- Covid-19
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Luftvägsinfektioner
- Infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- Patologiska tillstånd, tecken och symtom
- Postakut covid-19 syndrom
Andra studie-ID-nummer
- Keto-Life For Long COVID
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- CSR
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