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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
干预措施: Lifestyle Intervention (Behavioral)
ketogenic metabolic therapy with lifestyle strategies (KMT-LS)
干预措施: Ketogenic Metabolic Therapy (Other)
结局指标
主要结局
Acceptability
时间窗: 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.
Feasibility
时间窗: 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.).
次要结局
- PROMIS-29(Baseline, Post-intervention (13 Week), and 3-month follow-up)
- Duke Activity Status Index(Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up)
- Modified Medical Research Council Dyspnea Scale(Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up)
- Malmö POTS Symptom Score(Baseline, Post-intervention (13 Weeks), and 3-month follow-up)
- Good Day/Bad Day Questionnaire(Baseline, Post-Intervention (13-Weeks), 3-Month Follow-up)
- Satisfaction with Life Scale(Baseline, Post-intervention (13-Weeks), and 3-month follow-up)
研究者
Dharma Colgan
Research Fellow
National University of Natural Medicine