Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones (NCT06511206) | Clinical Trial Compass
CompletedNot Applicable
Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
Netherlands11 participantsStarted 2024-08-08
Plain-language summary
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
Who can participate
Age range
60 Years – 80 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:
* Aged 60-80 years
* Body mass index (BMI) 25-35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Exclusion Criteria:
* Type 2 diabetes
* Pre-diabetes based on one or a combination of the following criteria:
* ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
* HbA1c of 5.7-6.4%.
* Participants with active congestive heart failure and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Alcohol consumption of \> 3 servings per day for man and \> 2 servings per day for woman
* Unstable body weight (weight gain or loss \> 5 kg in the last 3 months)
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
* Significant food allergies/intolerance (seriously hampering study meals)
* Participants who do not want to be informed about unexpected medical findings
* Blood donation during or within 2 months prior to the study
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.