Effects of eating and fasting on ketone metabolism
Characterizing the Influence of Exogenous Ketosis on Circulating and Hepatic Metabolism in a Postprandial and Postabsorptive State in Adults Free From Metabolic Disease
This study tests how eating or fasting affects how the body uses ketones in healthy adults by giving them a special drink and checking their blood and breath.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06320522 on ClinicalTrials.gov |
What this trial studies
This study investigates how the state of feeding (fed vs. fasted) influences the metabolism of exogenous ketones in healthy adults. Participants will consume a high-carbohydrate diet before attending four visits where they will receive either a ketone monoester or a placebo drink. Blood and breath samples will be collected to assess the kinetics of βHB and its impact on metabolism. The study aims to clarify the relationship between feeding status and metabolic responses to exogenous ketosis.
Who should consider this trial
Good fit: Ideal candidates are healthy, pre-menopausal women who consume a mixed macronutrient diet and are not on any medications.
Not a fit: Patients with significant cardiovascular disease, metabolic risk factors, or those who have followed a ketogenic diet recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing dietary strategies for metabolic health and performance.
How similar studies have performed: While studies on ketosis exist, this specific investigation of feeding state effects on exogenous ketone metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Habitually consuming a mixed macronutrient diet * Fluent in English, no communication impairments, willing \& able to give informed consent for participation in the study * Not currently taking any medication (except the contraceptive pill) * No food allergies incompatible with the supplement drinks or with the standardised breakfast where a suitable substitution cannot be practically made * Female-only - on contraception (pill/implant/coil/etc); not pregnant/currently breastfeeding; pre-menopausal; not undertaking hormone replacement therapy (HRT) * In the investigator's opinion - able and willing to comply with all study requirements Exclusion Criteria: * Significant cardiovascular disease or metabolic risk factors, or family history of it, on health screening questionnaire * Food allergies incompatible with the supplement drinks or standardised breakfast * Having been on a ketogenic diet in the 6 months prior to enrolment * Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study/the participant's ability to participate in the study * Concurrently a participant in any other dietary intervention study/have taken part in one within 1 month of enrolment * Diabetic * Pregnant or breastfeeding * Known history of moderate-to-severe motion sickness
Where this trial is running
Oxford, Oxfordshire
- Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM) — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Leanne Hodson, PhD
- Email: leanne.hodson@ocdem.ox.ac.uk
- Phone: 01865 857224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.