此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年8月3日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

11

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Oregon
      • Portland、Oregon、美国、97229
        • National University of Natural Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
其他：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.

行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Acceptability
大体时间：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
大体时间：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).

次要结果测量

结果测量
措施说明
大体时间
PROMIS-29
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National University of Natural Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月10日

初级完成 (实际的)

2025年6月1日

研究完成 (实际的)

2025年6月1日

研究注册日期

首次提交

2026年7月29日

首先提交符合 QC 标准的

2026年8月2日

首次发布 (实际的)

2026年8月4日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2024年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Keto-Life For Long COVID

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Deidentified clinical data

IPD 共享时间框架

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 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅