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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97229
- National University of Natural Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acceptability
기간: Acceptability data was collected at post-intervention (Week 13).
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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.
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Acceptability data was collected at post-intervention (Week 13).
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Feasibility
기간: Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).
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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.).
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Acceptability data was collected during at baseline, Weeks 1-12, and post-intervention (Week 13).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PROMIS-29
기간: Baseline, Post-intervention (13 Week), and 3-month follow-up
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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
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Baseline, Post-intervention (13 Week), and 3-month follow-up
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Duke Activity Status Index
기간: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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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 .
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Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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Modified Medical Research Council Dyspnea Scale
기간: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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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.
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Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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Malmö POTS Symptom Score
기간: Baseline, Post-intervention (13 Weeks), and 3-month follow-up
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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.
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Baseline, Post-intervention (13 Weeks), and 3-month follow-up
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Good Day/Bad Day Questionnaire
기간: Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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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.
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Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up
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Satisfaction with Life Scale
기간: Baseline, Post-intervention (13-Weeks), and 3-month follow-up
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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).
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Baseline, Post-intervention (13-Weeks), and 3-month follow-up
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Keto-Life For Long COVID
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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