Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD (NCT07664111) | Clinical Trial Compass
CompletedNot Applicable
Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD
Turkey (Türkiye)34 participantsStarted 2025-08-15
Plain-language summary
Chronic obstructive pulmonary disease (COPD) is associated with persistent airflow limitation, systemic inflammation, reduced exercise capacity, and unfavorable changes in body composition. Nutritional interventions may represent a complementary strategy to improve clinical outcomes in individuals with COPD.
This pilot randomized controlled trial evaluates the feasibility, safety, and preliminary effectiveness of an 8-week ketogenic dietary intervention in men with mild-to-moderate COPD. Participants are randomly assigned to either a supervised ketogenic diet or a control group receiving standard dietary advice. The ketogenic diet restricts carbohydrate intake and promotes nutritional ketosis, which is monitored using blood beta-hydroxybutyrate measurements.
The primary outcome is change in the FEV1/FVC ratio. Secondary outcomes include systemic inflammation assessed by C-reactive protein (CRP), phase angle measured by bioelectrical impedance analysis, functional exercise capacity assessed by the 6-minute walk test, estimated aerobic capacity, body composition, and selected biochemical safety markers. The study aims to provide preliminary evidence regarding whether a ketogenic dietary approach may improve inflammatory status, functional capacity, and physiological outcomes in individuals with COPD.
Who can participate
Age range
40 Years – 75 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male sex
* Age between 40 and 75 years
* Clinically stable chronic obstructive pulmonary disease (COPD)
* GOLD stage I or II COPD
* No acute COPD exacerbation within the previous 3 months
* Stable pharmacological treatment for at least 4 weeks before enrollment
* Ability to complete study assessments and comply with dietary instructions
* Provision of written informed consent
Exclusion Criteria:
* GOLD stage III or IV COPD
* Uncontrolled cardiovascular disease
* Chronic kidney disease
* Severe hepatic dysfunction
* Active malignancy
* Insulin-dependent diabetes mellitus
* Participation in another dietary intervention program within the previous 3 months
* Inability to complete study assessments
* Contraindications to dietary carbohydrate restriction
* Refusal or inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FEV1/FVC Ratio
Timeframe: Change in the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC), assessed by spirometry after 8 weeks of intervention.