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COMPLETED
NCT07745699
NA

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

Sponsor: National University of Natural Medicine

View on ClinicalTrials.gov

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.

Official title: 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 the Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) and Postural Orthostatic Tachycardia Syndrome (POTS) Phenotypes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2024-12-10

Completion Date

2025-06-01

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

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.

Locations (1)

National University of Natural Medicine

Portland, Oregon, United States