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Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD (COPDKETO)

5 augustus 2026 bijgewerkt door: Dursun Alper YILMAZ, Agri Ibrahim Cecen University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

34

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: Standard Dietary Advice
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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FEV1/FVC Ratio
Tijdsspanne: 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
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
C-Reactive Protein (CRP)
Tijdsspanne: Baseline and Week 8
Serum C-reactive protein concentration (mg/L) measured as a marker of systemic inflammation.
Baseline and Week 8
Phase Angle
Tijdsspanne: Baseline and Week 8
Change in phase angle measured by multifrequency bioelectrical impedance analysis.
Baseline and Week 8
6-Minute Walk Distance
Tijdsspanne: Baseline and Week 8
Change in functional exercise capacity assessed by the 6-minute walk test.
Baseline and Week 8
Body Mass Index
Tijdsspanne: Baseline and Week 8
Baseline and Week 8Change in body mass index calculated as weight divided by height squared.
Baseline and Week 8
Fat Mass
Tijdsspanne: Baseline and Week 8
Baseline and Week 8Change in body fat mass measured by bioelectrical impedance analysis.
Baseline and Week 8
Estimated VO2max
Tijdsspanne: Baseline and Week 8
Baseline and Week 8Change in estimated maximal oxygen uptake derived from 6-minute walk performance.
Baseline and Week 8

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Agri Ibrahim Cecen University

Onderzoekers

  • Studie stoel: Dursun Alper YILMAZ, Ağrı İbrahim Çeçen Üniversitesi

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Werkelijk)

15 mei 2026

Studie voltooiing (Werkelijk)

15 juni 2026

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AICU-COPD-KETO-RCT-2026
  • SABF.25.003 (Ander subsidie-/financieringsnummer: Ağrı İbrahim Çeçen University Scientific Research Projects Unit (BAP))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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