Chronic Obstructive Pulmonary Disease (COPD)COPDKETONCT07664111
Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD
A study testing Ketogenic diet and Standard Dietary Advice in people with Chronic Obstructive Pulmonary Disease (COPD), run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ketogenic diet and Standard Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- GOLD stage III or IV COPD
- Uncontrolled cardiovascular disease
- Chronic kidney disease
- Severe hepatic dysfunction
- Active malignancy
- Insulin-dependent diabetes mellitus
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation, chronic inflammation, exercise intolerance, and alterations in body composition. In addition to pulmonary impairment, systemic manifestations such as increased inflammatory burden, skeletal muscle dysfunction, and adverse metabolic changes contribute substantially to morbidity and reduced quality of life. Nutritional interventions have therefore emerged as potential adjunctive strategies in COPD management.
Ketogenic diets are characterized by marked carbohydrate restriction, moderate protein intake, and increased dietary fat consumption, resulting in nutritional ketosis. Potential mechanisms relevant to COPD include reductions in systemic inflammation, changes in substrate utilization, reductions in adiposity, and alterations in respiratory gas exchange. However, randomized controlled studies investigating ketogenic dietary interventions in COPD remain limited.
This study is an 8-week, single-center, parallel-group pilot randomized controlled trial conducted in clinically stable men with GOLD stage I-II COPD. Participants are randomly allocated in a 1:1 ratio to either a ketogenic dietary intervention or a control group receiving standard dietary advice. The ketogenic diet is individually prescribed by a dietitian and aims to provide 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 is monitored using capillary beta-hydroxybutyrate measurements obtained throughout the intervention period. Pulmonary function is assessed using spirometry. Body composition and phase angle are measured using multifrequency bioelectrical impedance analysis. Functional exercise capacity is evaluated using the 6-minute walk test, and estimated aerobic capacity is derived from walking performance. Blood samples are collected to assess inflammatory and safety-related biomarkers, including C-reactive protein, lipid parameters, alanine aminotransferase, and creatinine.
The primary objective is to determine whether an 8-week ketogenic dietary intervention improves FEV1/FVC compared with standard dietary advice. Secondary objectives are to evaluate effects on systemic inflammation, phase angle, exercise capacity, body composition, and biochemical safety outcomes. As a pilot trial, the study is designed to generate effect-size estimates, assess feasibility and adherence, and inform the design of future larger multicenter randomized controlled trials.
- Being tested
- Ketogenic diet, Standard Dietary Advice
- Keywords
- COPD, Ketogenic Diet, Nutritional Ketosis, Pulmonary Function, Body Composition
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietBehavioural
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.
Standard Dietary AdviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | 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. Receives: Behavioral: Ketogenic diet |
| Standard Dietary Advice | Active comparator | Participants received standard dietary recommendations for chronic obstructive pulmonary disease and were instructed to maintain their habitual dietary patterns throughout the 8-week study period. Receives: Behavioral: Standard Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC Ratio
Baseline and Week 8
Measured: 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.
Secondary outcomes (6)
C-Reactive Protein (CRP)
Serum C-reactive protein concentration (mg/L) measured as a marker of systemic inflammation.
Measured: Baseline and Week 8
Phase Angle
Change in phase angle measured by multifrequency bioelectrical impedance analysis.
Measured: Baseline and Week 8
6-Minute Walk Distance
Change in functional exercise capacity assessed by the 6-minute walk test.
Measured: Baseline and Week 8
Body Mass Index
Baseline and Week 8Change in body mass index calculated as weight divided by height squared.
Measured: Baseline and Week 8
Fat Mass
Baseline and Week 8Change in body fat mass measured by bioelectrical impedance analysis.
Measured: Baseline and Week 8
Estimated VO2max
Baseline and Week 8Change in estimated maximal oxygen uptake derived from 6-minute walk performance.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2026
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to either a supervised ketogenic dietary intervention or a control group receiving standard dietary advice. Outcomes were assessed at baseline and after 8 weeks.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dursun Alper YILMAZ, Agri Ibrahim Cecen University
- Investigators
- Dursun Alper YILMAZ, Study chair, Ağrı İbrahim Çeçen Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664111
- Sponsor's protocol ID
- AICU-COPD-KETO-RCT-2026
- Other IDs
- SABF.25.003
- Acronym
- COPDKETO
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing has not yet been determined. Data sharing decisions will be made after publication of the primary study results and will be subject to institutional policies, ethical considerations, participant confidentiality requirements, and applicable data protection regulations.
Publications
Ji J, Fotros D, Sohouli MH, Velu P, Fatahi S, Liu Y. The effect of a ketogenic diet on inflammation-related markers: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev. 2025 Jan 1;83(1):40-58. doi: 10.1093/nutrit/nuad175.
PubMed 38219223Norwitz NG, Winwood R, Stubbs BJ, D'Agostino DP, Barnes PJ. Case Report: Ketogenic Diet Is Associated With Improvements in Chronic Obstructive Pulmonary Disease. Front Med (Lausanne). 2021 Jul 29;8:699427. doi: 10.3389/fmed.2021.699427. eCollection 2021.
PubMed 34395478Maddocks M, Kon SS, Jones SE, Canavan JL, Nolan CM, Higginson IJ, Gao W, Polkey MI, Man WD. Bioelectrical impedance phase angle relates to function, disease severity and prognosis in stable chronic obstructive pulmonary disease. Clin Nutr. 2015 Dec;34(6):1245-50. doi: 10.1016/j.clnu.2014.12.020. Epub 2015 Jan 7.
PubMed 25597016Collins PF, Yang IA, Chang YC, Vaughan A. Nutritional support in chronic obstructive pulmonary disease (COPD): an evidence update. J Thorac Dis. 2019 Oct;11(Suppl 17):S2230-S2237. doi: 10.21037/jtd.2019.10.41.
PubMed 31737350Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
PubMed 35279265
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07664111
- Acronym / sponsor ID
- COPDKETO / AICU-COPD-KETO-RCT-2026
- Keywords
- COPD, Ketogenic Diet, Nutritional Ketosis, Pulmonary Function, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation, chronic inflammation, exercise intolerance, and alterations in body composition. In addition to pulmonary impairment, systemic manifestations such as increased inflammatory burden, skeletal muscle dysfunction, and adverse metabolic changes contribute substantially to morbidity and reduced quality of life. Nutritional interventions have therefore emerged as potential adjunctive strategies in COPD management.
Ketogenic diets are characterized by marked carbohydrate restriction, moderate protein intake, and increased dietary fat consumption, resulting in nutritional ketosis. Potential mechanisms relevant to COPD include reductions in systemic inflammation, changes in substrate utilization, reductions in adiposity, and alterations in respiratory gas exchange. However, randomized controlled studies investigating ketogenic dietary interventions in COPD remain limited.
This study is an 8-week, single-center, parallel-group pilot randomized controlled trial conducted in clinically stable men with GOLD stage I-II COPD. Participants are randomly allocated in a 1:1 ratio to either a ketogenic dietary intervention or a control group receiving standard dietary advice. The ketogenic diet is individually prescribed by a dietitian and aims to provide 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 is monitored using capillary beta-hydroxybutyrate measurements obtained throughout the intervention period. Pulmonary function is assessed using spirometry. Body composition and phase angle are measured using multifrequency bioelectrical impedance analysis. Functional exercise capacity is evaluated using the 6-minute walk test, and estimated aerobic capacity is derived from walking performance. Blood samples are collected to assess inflammatory and safety-related biomarkers, including C-reactive protein, lipid parameters, alanine aminotransferase, and creatinine.
The primary objective is to determine whether an 8-week ketogenic dietary intervention improves FEV1/FVC compared with standard dietary advice. Secondary objectives are to evaluate effects on systemic inflammation, phase angle, exercise capacity, body composition, and biochemical safety outcomes. As a pilot trial, the study is designed to generate effect-size estimates, assess feasibility and adherence, and inform the design of future larger multicenter randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either a supervised ketogenic dietary intervention or a control group receiving standard dietary advice. Outcomes were assessed at baseline and after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Behavioral: Ketogenic dietParticipants 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. |
| Standard Dietary Advice | Active comparator | Behavioral: Standard Dietary AdviceParticipants received standard dietary recommendations for chronic obstructive pulmonary disease and were instructed to maintain their habitual dietary patterns throughout the 8-week study period. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- GOLD stage III or IV COPD
- Uncontrolled cardiovascular disease
- Chronic kidney disease
- Severe hepatic dysfunction
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietParticipants 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. | Behavioural | Ketogenic Diet |
| Standard Dietary AdviceParticipants received standard dietary recommendations for chronic obstructive pulmonary disease and were instructed to maintain their habitual dietary patterns during the 8-week study period. | Behavioural | Standard Dietary Advice |
Primary outcome
FEV1/FVC Ratio
Time frame: 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.
Baseline and Week 8
6 secondary outcomes
C-Reactive Protein (CRP)
Time frame: Baseline and Week 8
Phase Angle
Time frame: Baseline and Week 8
6-Minute Walk Distance
Time frame: Baseline and Week 8
Body Mass Index
Time frame: Baseline and Week 8
Fat Mass
Time frame: Baseline and Week 8
Estimated VO2max
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 38219223Ji J, Fotros D, Sohouli MH, Velu P, Fatahi S, Liu Y. The effect of a ketogenic diet on inflammation-related markers: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev. 2025 Jan 1;83(1):40-58. doi: 10.1093/nutrit/nuad175.
- Results publication: PubMed 34395478Norwitz NG, Winwood R, Stubbs BJ, D'Agostino DP, Barnes PJ. Case Report: Ketogenic Diet Is Associated With Improvements in Chronic Obstructive Pulmonary Disease. Front Med (Lausanne). 2021 Jul 29;8:699427. doi: 10.3389/fmed.2021.699427. eCollection 2021.
- Results publication: PubMed 25597016Maddocks M, Kon SS, Jones SE, Canavan JL, Nolan CM, Higginson IJ, Gao W, Polkey MI, Man WD. Bioelectrical impedance phase angle relates to function, disease severity and prognosis in stable chronic obstructive pulmonary disease. Clin Nutr. 2015 Dec;34(6):1245-50. doi: 10.1016/j.clnu.2014.12.020. Epub 2015 Jan 7.
- Results publication: PubMed 31737350Collins PF, Yang IA, Chang YC, Vaughan A. Nutritional support in chronic obstructive pulmonary disease (COPD): an evidence update. J Thorac Dis. 2019 Oct;11(Suppl 17):S2230-S2237. doi: 10.21037/jtd.2019.10.41.
- Results publication: PubMed 35279265Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing has not yet been determined. Data sharing decisions will be made after publication of the primary study results and will be subject to institutional policies, ethical considerations, participant confidentiality requirements, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dursun Alper YILMAZ study chair
Ağrı İbrahim Çeçen Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and Standard Dietary Advice in people with Chronic Obstructive Pulmonary Disease (COPD), run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1/FVC Ratio (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.