MedTrace Logo

Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD

NCT07664111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-08-07

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

BEHAVIORAL

Ketogenic diet

Participants received an individualized ketogenic dietary intervention for 8 weeks. The dietary prescription provided approximately 60-70% of total energy from fat, 15-20% from protein, and 5-10% from carbohydrates, with carbohydrate intake restricted to less than 50 g/day. Nutritional ketosis was monitored using blood beta-hydroxybutyrate measurements throughout the intervention period.

BEHAVIORAL

Standard Dietary Advice

Participants received standard dietary recommendations for chronic obstructive pulmonary disease and were instructed to maintain their habitual dietary patterns during the 8-week study period.

Sponsors & Collaborators

  • Agri Ibrahim Cecen University

    lead OTHER

Principal Investigators

  • Dursun Alper YILMAZ · Ağrı İbrahim Çeçen Üniversitesi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-15
Completion
2026-06-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664111 on ClinicalTrials.gov