Short Term Ketone Supplementation and Cardiometabolic Health (NCT04236388) | Clinical Trial Compass
CompletedNot Applicable
Short Term Ketone Supplementation and Cardiometabolic Health
United States11 participantsStarted 2020-10-02
Plain-language summary
The purpose of this research study is to determine if short-term consumption of a dietary ketone drink, which increases the blood circulation concentrations of beta-hydroxybutyrate, a ketone, affects blood vessel health and cognitive health in adults. Ketones are normally produced by the liver when people fast longer than 16-24 hours or eat a diet low in carbohydrates. Participants will be asked to randomly consume a dietary ketone drink and placebo (flavored water) for a 2-week period each in a crossover fashion with a 2-week washout period while maintaining habitual diet and physical activity patterns.
The investigators hypothesize that consumption of a ketone drink will reduce BP and improve vascular health by reducing aortic pulse wave velocity and increasing brachial artery flow mediated dilation. Furthermore, they hypothesize that ketone consumption will improve cognitive health by increasing attention and processing speed.
Who can participate
Age range
50 Years – 75 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:
* Ability to provide informed consent
* 50-75 years of age
* Systolic blood pressure \<160 mmHg
* Diastolic blood pressure \<100 mmHg
* Sedentary to recreationally active
* Body Mass Index \<35 kg/m\^2
* Postmenopausal women must be \>1 year since last menses
Exclusion Criteria:
* Current smoker
* Pregnant or planning to become pregnant
* Dyslipidemia (Total cholesterol \>240 mg/dL, LDL \>160 mg/dL)
* Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, unstable coronary heart disease, stroke, heart failure, diabetes, neurological disorders)
* Following an extreme dietary pattern or planning to change to one (e.g., low carbohydrate, carnivore)
* Not weight stable in the prior 3 months (\>2 kg weight change)
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 Arterial Stiffness after Supplementation
Timeframe: 45-minute measurement in laboratory
2
Change in Brachial Artery Function after Supplementation
Timeframe: 30-minute measurement in laboratory
Trial details
NCT IDNCT04236388
SponsorVirginia Polytechnic Institute and State University