Exogenous Ketosis in a Fed and a Fasted State (NCT06320522) | Clinical Trial Compass
CompletedNot Applicable
Exogenous Ketosis in a Fed and a Fasted State
United Kingdom12 participantsStarted 2023-02-15
Plain-language summary
The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.
This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.
As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.
Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma β-hydroxybutyrate (βHB) kinetics
Timeframe: 7 hours (fasted arrival through to 6 hours after consumption of the KME or PLA drink)
2
Plasma glucose kinetics
Timeframe: 7 hours (fasted arrival through to 6 hours after consumption of the KME or PLA drink)
3
Postprandial de novo lipogenesis (DNL)
Timeframe: 7 hours (fasted arrival through to 6 hours after consumption of the KME or PLA drink)