Assessment of BHB Concentration Agreement Among Sampling Locations and the Impact of Ketosis on E… (NCT06053138) | Clinical Trial Compass
CompletedNot Applicable
Assessment of BHB Concentration Agreement Among Sampling Locations and the Impact of Ketosis on EPO, and More
Denmark16 participantsStarted 2023-08-24
Plain-language summary
This study aims to address two key aspects. First, the suitability of selecting a specific sampling site for BHB measurement in patients and research, as well as potential differences between capillary and venous blood measurements. Additionally, the study will investigate the effects of ketosis on EPO concentrations, sex hormone levels, hemodynamic markers, and blood pressure.
This investigation will utilize blood samples collected from baseline and at Day 15, between which participants are exposed to intermittent ketosis or placebo in a randomized parallel design.
Who can participate
Age range
18 Years – 60 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:
* Age 18-60 years
* BMI 19-30 kg/m2
* Expected ease of catheter insertion
* Considered of sound health
* Oral and written informed consent
Exclusion Criteria:
* Inability to fully understand the consent including consent forms
* Inability to cooperate to the study
* electrolyte disorders
* acute or chronic kidney disease or ompromised renal function including excess risk
* servere hypertension
* autoimmune disease
* liver or bile disease
* diabetes mellitus
* reactive hypoglycemia or similar disorders
* treatment with drugs, and dietary supplements with inference on key metabolic or hormonal markers, e.g. insulin, glucagon, DDP-IV inhibitors, GLP-1 RA, sulfunylurea
* use of illegal or otherwise use of medicinal products without prescription
* anemia or other know disease of the hematopoietic system
* previous bariatric surgery
* previous myocardial infarction or uncontrolled myocardial ischemia
* recent intended/unintended weight loss
* allergies to catheters or adhesives
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
Change in Venous Plasma Beta-hydroxybutyrate (BHB) From Baseline to Peak During Acute Ketosis Exposure
Timeframe: Baseline (0 minutes) to peak concentration during acute ketosis exposure (0-180 minutes)