NCT07664111Completed
Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD
Effects of an 8-Week Ketogenic Dietary Intervention on Pulmonary Function, Systemic Inflammation, Body Composition, and Functional Exercise Capacity in Men With Mild-to-Moderate Chronic Obstructive Pulmonary Disease: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 15 Jun 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 15 May 2026
- Lead sponsor
- Agri Ibrahim Cecen University
- Diseases
- COPD
- NCT number
- NCT07664111
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Jan 2026 to the primary completion date, 15 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another dietary intervention program within the previous 3 months
Other illness
- Uncontrolled cardiovascular disease
- Chronic kidney disease
- Active malignancy
- Insulin-dependent diabetes mellitus
Other
- GOLD stage III or IV COPD
- Severe hepatic dysfunction
- Inability to complete study assessments
- Contraindications to dietary carbohydrate restriction
- Refusal or inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ağrı İbrahim Çeçen University Coordinator of this site? Confirm its status | Ağrı | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.