Exogenous Ketosis in a Fed and a Fasted State

Launched by UNIVERSITY OF OXFORD · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how the body processes a special drink called a ketone monoester, which can help people achieve a state known as ketosis. Ketosis is when your body burns fat for energy instead of sugar. The researchers want to see how this process works differently when participants have eaten a meal compared to when they have not eaten anything (fasting). They also aim to understand if drinking this ketone drink affects metabolism, which is how your body converts food into energy, especially in relation to conditions like type II diabetes and fatty liver disease.

To participate, individuals aged 18 to 75 who eat a balanced diet and are fluent in English can apply. They should not be taking any medications (except contraceptives) or have certain health issues, such as significant heart problems or diabetes. Participants will be asked to drink either the ketone drink or a placebo (a non-active drink) under both fasting and fed conditions. This study is currently recruiting participants, and those who join can expect to help researchers learn about how diet affects metabolism and overall health.

Gender

ALL

Eligibility 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